SetPoint Medical Corporation — Biomedical Watch V2

Traitements14programmes

Essais6liés

Publications20liées

SourceDBlocale

Traitements

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Active stimulationThe MS pilot study will assess the safety and investigate the remyelinating effects of the SetPoint System (study device) in adult patients with patients diagnosed with relapsing-remitting multiple sclerosis (RRMS). The SetPoint System is intended for adjunctive use with standard of care therapy for RRMS. The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll up to 60 participants at up to 10 sites. All eligible participants will undergo the implant procedure. Two-thirds of the participants will receive active stimulation (treatment) and the one-third will receive non-active stimulation (control). Following treatment evaluations at Week 48, there will be a one-way crossover of control subjects to active stimulation and a 48-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.	SEP	Non applicable	Remyélinisation	United States	À vérifier
Conventional Synthetic DMARDThe RESET-RA study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult patients with active, moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll up to 250 subjects at up to 45 sites. All eligible subjects will undergo the implant procedure. Half of the subjects will receive active stimulation (treatment) and the other half will receive non-active stimulation (control). After completing primary endpoint assessments at Week 12, there will be a one-way crossover of control subjects to active stimulation and a 252-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.	SEP	Phase 3	À vérifier	United States	À vérifier
Disease-Modifying Therapies (DMTs)PENTAGON is an observational, non-interventional, multicenter, prospective cohort study conducted at approximately 20 neurology centers and affiliated radiology centers across Germany. It investigates whether loss of thalamic volume (TVL) is an independent driver of disability progression in patients with relapsing-remitting multiple sclerosis (MS). The study observes two groups: patients with active MS (receiving or about to receive first- or second-line disease-modifying therapies) and patients with progressive MS. Over a 24-month primary observation period - extendable to 72 months - MS-related disability is measured with the Expanded Disability Status Scale (EDSS), and whole-brain and thalamic volumes are quantified from standardized high-resolution T1-weighted MRI using validated deep-learning methods. The primary objective is to demonstrate that the change in MS-related disability over 24 months is inversely associated with the change in thalamic volume over the same period. No procedures beyond routine clinical care are required.	SEP	Non applicable	Remyélinisation	United States	À vérifier
Implant ProcedureThe RESET-RA study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult patients with active, moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll up to 250 subjects at up to 45 sites. All eligible subjects will undergo the implant procedure. Half of the subjects will receive active stimulation (treatment) and the other half will receive non-active stimulation (control). After completing primary endpoint assessments at Week 12, there will be a one-way crossover of control subjects to active stimulation and a 252-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.	SEP	Non applicable	Remyélinisation	United States	À vérifier
Non-active stimulationThe MS pilot study will assess the safety and investigate the remyelinating effects of the SetPoint System (study device) in adult patients with patients diagnosed with relapsing-remitting multiple sclerosis (RRMS). The SetPoint System is intended for adjunctive use with standard of care therapy for RRMS. The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll up to 60 participants at up to 10 sites. All eligible participants will undergo the implant procedure. Two-thirds of the participants will receive active stimulation (treatment) and the one-third will receive non-active stimulation (control). Following treatment evaluations at Week 48, there will be a one-way crossover of control subjects to active stimulation and a 48-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.	SEP	Non applicable	Remyélinisation	United States	À vérifier
Procedure/Surgery: Implant ProcedureThe MS pilot study will assess the safety and investigate the remyelinating effects of the SetPoint System (study device) in adult patients with patients diagnosed with relapsing-remitting multiple sclerosis (RRMS). The SetPoint System is intended for adjunctive use with standard of care therapy for RRMS. The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll up to 60 participants at up to 10 sites. All eligible participants will undergo the implant procedure. Two-thirds of the participants will receive active stimulation (treatment) and the one-third will receive non-active stimulation (control). Following treatment evaluations at Week 48, there will be a one-way crossover of control subjects to active stimulation and a 48-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.	SEP	Non applicable	Remyélinisation	United States	À vérifier
SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway SystemLong-term extension of a multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two biologic and/or targeted synthetic DMARDs having at least two different mechanisms of action	SEP	Non applicable	Immunomodulation	United States	À vérifier
SetPoint SystemProspective, multicenter, post-market, registry study designed to systematically collect real-world data (RWD) from participants implanted with the SetPoint System \[implanted, vagus-mediated, neuroimmune modulator\] for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). The registry will assess adherence to surgical training, device performance, system usability, safety, and clinical outcomes as reported in clinical practice.	SEP	À vérifier			À vérifier
Disease-Modifying Therapies (DMTs)PENTAGON is an observational, non-interventional, multicenter, prospective cohort study conducted at approximately 20 neurology centers and affiliated radiology centers across Germany. It investigates whether loss of thalamic volume (TVL) is an independent driver of disability progression in patients with relapsing-remitting multiple sclerosis (MS). The study observes two groups: patients with active MS (receiving or about to receive first- or second-line disease-modifying therapies) and patients with progressive MS. Over a 24-month primary observation period - extendable to 72 months - MS-related disability is measured with the Expanded Disability Status Scale (EDSS), and whole-brain and thalamic volumes are quantified from standardized high-resolution T1-weighted MRI using validated deep-learning methods. The primary objective is to demonstrate that the change in MS-related disability over 24 months is inversely associated with the change in thalamic volume over the same period. No procedures beyond routine clinical care are required.	SEP	À vérifier	Remyélinisation	Germany	À vérifier
Implant ProcedureThe RESET-RA study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult patients with active, moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll up to 250 subjects at up to 45 sites. All eligible subjects will undergo the implant procedure. Half of the subjects will receive active stimulation (treatment) and the other half will receive non-active stimulation (control). After completing primary endpoint assessments at Week 12, there will be a one-way crossover of control subjects to active stimulation and a 252-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.	SEP	Non applicable	Remyélinisation	United States	À vérifier
Implant ProcedureThe RESET-RA study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult patients with active, moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll up to 250 subjects at up to 45 sites. All eligible subjects will undergo the implant procedure. Half of the subjects will receive active stimulation (treatment) and the other half will receive non-active stimulation (control). After completing primary endpoint assessments at Week 12, there will be a one-way crossover of control subjects to active stimulation and a 252-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.	SEP	Phase 3	Remyélinisation	United States	À vérifier
SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway SystemLong-term extension of a multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two biologic and/or targeted synthetic DMARDs having at least two different mechanisms of action	SEP	Non applicable	Immunomodulation	United States	À vérifier
SetPoint SystemProspective, multicenter, post-market, registry study designed to systematically collect real-world data (RWD) from participants implanted with the SetPoint System \[implanted, vagus-mediated, neuroimmune modulator\] for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). The registry will assess adherence to surgical training, device performance, system usability, safety, and clinical outcomes as reported in clinical practice.	SEP	À vérifier			À vérifier
SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway SystemLong-term extension of a multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two biologic and/or targeted synthetic DMARDs having at least two different mechanisms of action	SEP	Non applicable	Immunomodulation	United States	À vérifier

Essais cliniques

Molécule	Indication / population	Phase	NCT	Titre	Statut
SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System	SEP	Non applicable	NCT03437473	Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)	COMPLETED
SetPoint System	SEP	À vérifier	NCT07489326	ACTIVATE — The SetPoint System Safety & Performance Post-Approval Study	NOT_YET_RECRUITING
SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System	SEP	Non applicable	NCT04862117	Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)	ACTIVE_NOT_RECRUITING
Implant Procedure	SEP	Phase 3	NCT04539964	RESET-RA — Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis	ACTIVE_NOT_RECRUITING
Implant Procedure	SEP	Non applicable	NCT06796504	The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study	RECRUITING
Disease-Modifying Therapies (DMTs)	SEP	À vérifier	NCT07753928	PENTAGON — MS-Related Disability Worsening and Thalamic Volume Loss	ENROLLING_BY_INVITATION

Publications

Molécule	Titre	Journal
SetPoint System	Polysaccharides-mediated mitochondrial remodeling: role in chemotherapy resistance of gastrointestinal tumors.	Phytomedicine : international journal of phytotherapy and phytopharmacology
SetPoint System	Fin-Ray soft gripper for object manipulation with multi-robot systems.	HardwareX
SetPoint System	Fundamental questions on closed-loop neuromodulation: a control theory perspective.	Cognitive neurodynamics
SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System	Neurostimulation of the cholinergic anti-inflammatory pathway ameliorates disease in rat collagen-induced arthritis.	PloS one
Conventional Synthetic DMARD	Experience of Australian rheumatologists managing polymyalgia rheumatica: results from a national survey.	Internal medicine journal
Conventional Synthetic DMARD	The Asia-Pacific League of Associations for Rheumatology Consensus Recommendations on the Management of Systemic Juvenile Idiopathic Arthritis (Juvenile Still's Disease).	International journal of rheumatic diseases
Conventional Synthetic DMARD	An iguratimod prodrug reduces RA-FLS invasiveness by disrupting STAT1-C3-TNFα-mediated crosstalk between fibroblast-like synoviocytes and macrophages.	Journal of orthopaedic translation
Implant Procedure	Edentulous patients' experiences with two-implant overdentures - A qualitative exploration.	Journal of dentistry
Implant Procedure	Cost-utility of implantable tibial neuromodulation (Revi) versus conservative therapy for urgency urinary incontinence in adults: a US payer perspective.	Journal of medical economics
Implant Procedure	A systematic review of acute and long-term outcomes in patients with non-transvenous implantable cardioverter-defibrillators.	Journal of medical economics
Non-active stimulation	Effect of transcutaneous auricular vagus nerve stimulation (taVNS) on inhibitory control as a function of motor task complexity.	Behavioural brain research
Active stimulation	Effect of intraoperative 40-hz gamma-frequency auditory stimulation on postoperative delirium in older adults undergoing major surgery: a randomized clinical trial protocol.	Annals of medicine
Disease-Modifying Therapies (DMTs)	Updates of spinal muscular atrophy in advanced therapies.	Journal of the Formosan Medical Association = Taiwan yi zhi
Disease-Modifying Therapies (DMTs)	A Retrospective Study of 116 Multiple Sclerosis Patients with Dimethyl Fumarate Treatment in a Single Institution in Japan.	Internal medicine (Tokyo, Japan)
Non-active stimulation	Determination of nanostructured human serum albumin assembly based on enhanced topological fluorescence lifetime decays by applying controlled spatial tiny gold Core-shell labelling.	Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy
Non-active stimulation	Effect of physical activity on paired-pulse suppression in the somatosensory cortex after tibial nerve stimulation.	Experimental brain research
Active stimulation	Observed changes in clinical proxy measures of airway protection after cervical epidural spinal cord stimulation in neurological disorders: a preliminary retrospective case series.	Frontiers in neurology
Active stimulation	Efficacy of a high-frequency repetitive transcranial magnetic stimulation for craving reduction in adolescents with gaming disorder: a 4-week randomized control trial with 24-week follow-up.	European archives of psychiatry and clinical neuroscience
Disease-Modifying Therapies (DMTs)	Cladribine treatment in pediatric-onset multiple sclerosis: real-world clinical outcomes and safety insights.	Frontiers in immunology
Disease-Modifying Therapies (DMTs)	Efficacy and safety of ofatumumab in participants with relapsing multiple sclerosis and breakthrough disease on oral fingolimod or fumarates: results from the ARTIOS study.	Journal of neurology