Clinical trials: sponsored by Boston Scientific Corporation
Glioblastoma Multiforme, Recurrent Glioblastoma
A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM
The FRONTIER Study is a prospective, interventional, single-arm, multi-center, study to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent GBM.
- Trial name
- FRONTIER (NCT05303467)
- Testing
- TheraSphere GBM
- Where
- 9 sites in United States
- Volunteers
- 36 people
- Sponsor
- Boston Scientific Corporation
Hepatocellular Carcinoma (HCC)
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
The purpose of this study is to assess the safety and effectiveness of treating a tumor using a different planning method called MCD for the FDA-Approved device, TheraSphere.
- Trial name
- ADVANCE-MCD (NCT07669727)
- Testing
- TheraSphere
- Volunteers
- 140 people
- Sponsor
- Boston Scientific Corporation
Carotid Artery Stenosis
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
The study is a prospective, non-randomized, single-arm, multi-center registry to confirm the safe delivery of the Carotid WALLSTENT Endoprosthesis when used with the ENROUTE® Transcarotid Neuroprotection System in the Chinese…
- Trial name
- ASCENT-C (NCT07458243)
- Testing
- transcarotid artery revascularization
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
Motor Epilepsy
Combined CM and STN Stimulation for Motor Epilepsy
This self-crossover, randomized controlled, pilot study aims to collect clinical data of bilateral stimulation of subthalamic nucleus (STN) combined with centromedian (CM) thalamus deep brain stimulation (DBS) for drug resistant…
- Trial name
- CoSMos (NCT07458217)
- Testing
- Deep brain stimulation
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Boston Scientific Corporation
Prostate, Cancer
Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device
The VOYAGER Study is an interventional, non-randomized, single-arm, dose escalation trial with the goal of determining the safety of TheraSphere PCa device in patients with clinically localized prostate cancer across US-based…
- Trial name
- VOYAGER (NCT06192758)
- Testing
- TheraSphere PCa
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Boston Scientific Corporation
Hepatocellular Carcinoma
TheraSphere With Durvalumab and Tremelimumab for HCC
The objective of the ROWAN clinical study is to assess the efficacy of local tumor control in HCC patients who receive TheraSphere followed by durvalumab and tremelimumab.
- Trial name
- ROWAN (NCT05063565)
- Testing
- TheraSphere Y-90 glass microsphere therapy, Durvalumab (Imfinzi) immunotherapy, Tremelimumab immunotherapy
- Where
- 35 sites in United States, France and 3 more
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Congestive Heart Failure
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and…
- Trial name
- NECTAR-HF (NCT01385176)
- Testing
- Implant of investigational device system, Titration during the randomization phase, Titration after the randomization phase
- Where
- 21 sites in Belgium, Czechia and 6 more
- Volunteers
- 118 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal AF
FARAPULSE™ Pulsed Field Ablation System
To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) system when used per hospitals' standard of care in Chinese population.
- Trial name
- NCT06762717
- Testing
- FARAPULSE™ Pulsed Field Ablation system
- Where
- China
- Volunteers
- 501 people
- Sponsor
- Boston Scientific Corporation
Weight Loss
OverStitch NXT Endoscopic Suture System
To demonstrate the safety and efficacy of OverStitch NXT Endoscopic Suture System for endoscopic sleeve gastroplasty（ESG） in obese populations to support the registration of OverStitch NXT for ESG indication.
- Trial name
- NCT07276815
- Testing
- OverStitch NXT Endoscopic Suture System
- Where
- China
- Volunteers
- 136 people
- Sponsor
- Boston Scientific Corporation
Bradycardia, Atrioventricular Block
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
The goal of this observational post-market clinical Follow-up study is to learn about the long-term safety, performance, and clinical benefits of pacing the left bundle branch area (LBBAP) using the INGEVITY+ pacemaker lead in…
- Conditions
- Bradycardia, Atrioventricular Block, Sinus Node Dysfunction, Bundle-Branch Block
- Trial name
- SEPTA PMCF (NCT07209852)
- Testing
- Pacemaker lead
- Where
- 13 sites in Belgium, France and 5 more
- Volunteers
- 140 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
OPTION-EMEA Clinical Trial
The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with…
- Conditions
- Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation, Left Atrial Appendage Closure, Pulsed Field Ablation
- Trial name
- OPTION-EMEA (NCT07349121)
- Testing
- Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case, Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure
- Where
- 11 sites in Belgium, Croatia and 3 more
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Weight Loss
Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')
To demonstrate the safety and efficacy of Orbera365 in obese populations to support the registration of Orbera365.
- Trial name
- NCT07195708
- Testing
- Treatment group
- Where
- China
- Volunteers
- 144 people
- Sponsor
- Boston Scientific Corporation
Cardiovascular Diseases
A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China
A prospective, observational, single-arm, open-label, multicenter, post-approval study. To compile real-world clinical outcomes data for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System…
- Trial name
- NCT03736226
- Testing
- SYNERGYTM Stent System
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Boston Scientific Corporation
Acute Pulmonary Embolism
A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary Embolism
This study to collect the real-world clinical outcome data of EkoSonicTM Endovascular System in Chinese patients with acute pulmonary embolism during practical clinical care.
- Trial name
- ANTEATER (NCT06819865)
- Testing
- EkoSonicTM Endovascular System
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Boston Scientific Corporation
Persistent Atrial Fibrillation
PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)
This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in…
- Trial name
- NCT07106970
- Testing
- Linear ablation, PVI alone
- Where
- China
- Volunteers
- 640 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation
The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial…
- Trial name
- FARADIGM (NCT07575269)
- Testing
- FARAFLEX Mapping and Pulsed Field Ablation (PFA) System
- Where
- 13 sites in United States, Belgium and 2 more
- Volunteers
- 571 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (AF), Persistant Atrial Fibrillation
A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation
The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources)…
- Trial name
- OPTIMIZE (NCT07187115)
- Testing
- FARAPOINT Pulsed Field Ablation System, OptiMap System (non-ablative), FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System
- Where
- 15 sites in United States, Belgium and 2 more
- Volunteers
- 699 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System
This is a multicenter, prospective, single-arm, feasibility study to evaluate the safety and effectiveness of the waveforms being delivered using the FARAPULSE PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and…
- Trial name
- IMPULSE-EVO (NCT07444320)
- Testing
- FARAPULSE™ Pulsed Field Ablation (PFA) System
- Where
- 4 sites in Croatia, Czechia and 2 more
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Concomitant Procedures, Atrial Fibrillation
cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia
Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and…
- Conditions
- Concomitant Procedures, Atrial Fibrillation, PFA, LAAC
- Trial name
- OPTION-A (NCT06686485)
- Testing
- FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
- Where
- 37 sites in China, Hong Kong and 4 more
- Volunteers
- 433 people
- Sponsor
- Boston Scientific Corporation
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
The goal of this clinical trial is to determine whether Endoscopic Sleeve Gastroplasty (ESG)-induced weight loss can improve glycemic outcomes and alter the trajectory toward insulin dependence in adults with obesity and…
- Trial name
- MEASURE (NCT07639684)
- Testing
- ESG with OverStitch
- Volunteers
- 50 people
- Sponsor
- Boston Scientific Corporation