Clinical trials: sponsored by Boston Scientific Corporation
Recurrent Glioblastoma
An Optimization Study Evaluating Safety and Efficacy of the Y-90 Glioblastoma (GBM) Device in Patients With Recurrent GBM
The purpose of this study is to test Y90 glass microspheres for people with recurrent brain cancer. Participation in this study will help researchers find the best dose for the treatment of the disease.
- Trial name
- ODYSSEY (NCT07867886)
- Testing
- Device: TheraSphere GBM treatment of TheraSphere GBM device
- Where
- 5 sites in France, Germany and 2 more
- Volunteers
- 30 people
- Sponsor
- Boston Scientific Corporation
Chronic Pain
Patient Retrospective Outcomes (PRO)
This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.
- Trial name
- PRO (NCT01550575)
- Testing
- Non Boston Scientific Systems, Boston Scientific Systems
- Where
- 145 sites in United States, Australia and 12 more
- Volunteers
- 15,000 people
- Sponsor
- Boston Scientific Corporation
Lumbar Spinal Stenosis
A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
- Trial name
- NCT04192591
- Testing
- Superion™ IDS device
- Where
- 23 sites in United States
- Volunteers
- 166 people
- Sponsor
- Boston Scientific Corporation
Gastric Outlet Obstruction
AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE
To investigate the safety and technical success of EUS-guided gastroenterostomy (EUS-GE) using the AXIOSTM lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant…
- Trial name
- NCT06174805
- Testing
- AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
- Where
- 10 sites in United States, Belgium and 4 more
- Volunteers
- 67 people
- Sponsor
- Boston Scientific Corporation
Parkinson Disease, Essential Tremor
Deep Brain Stimulation (DBS) Retrospective Outcomes Study
The primary objective of this study is to characterize real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.
- Conditions
- Parkinson Disease, Essential Tremor, Dystonia
- Trial name
- NCT03664609
- Testing
- Deep Brain Stimulation
- Where
- 20 sites in United States, Belgium and 4 more
- Volunteers
- 5,000 people
- Sponsor
- Boston Scientific Corporation
Obesity
Safety and Effectiveness of Orbera365™ Intragastric Balloon System
This is a prospective, multi-center, standard of care registry offered to subjects in the EU only that have already agreed to receive the Orbera365™ Intragastric Balloon (IGB) System for weight loss.
- Trial name
- Orbera365 (NCT07062094)
- Testing
- Intragastric Balloon
- Where
- 4 sites in Czechia, Spain and 1 more
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Heart Failure
LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.
- Trial name
- NCT04790344
- Testing
- Investigational LUX-Dx ICM Implant
- Where
- 57 sites in United States
- Volunteers
- 557 people
- Sponsor
- Boston Scientific Corporation
Parkinson Disease
Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation
The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.
- Trial name
- CLOVER (NCT03037398)
- Testing
- Vercise Deep Brain Stimulation System
- Where
- 3 sites in Germany
- Volunteers
- 69 people
- Sponsor
- Boston Scientific Corporation
Non-valvular Atrial Fibrillation (AF), Left Atrial Appendage Closure
WATCHMAN FLX Pro European Registry
The WATCHMAN FLX Pro European registry is intended to gather real world clinical data for patients undergoing left atrial appendage closure (LAAC) with the WATCHMAN FLX™ Pro device.
- Trial name
- NCT07262255
- Testing
- Left atrial appendage closure
- Where
- 20 sites in Denmark, Germany and 4 more
- Volunteers
- 189 people
- Sponsor
- Boston Scientific Corporation
ACC/AHA/NASPE Class 1, IIa or IIb Indications
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure.
- Trial name
- NCT01117792
- Testing
- subcutaneous implantable defibrillator (S-ICD) system
- Where
- 8 sites in Italy, Netherlands and 2 more
- Volunteers
- 55 people
- Sponsor
- Boston Scientific Corporation
Aortic Stenosis
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
- Trial name
- NCT03735667
- Testing
- ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System
- Where
- 75 sites in United States, Canada
- Volunteers
- 1,948 people
- Sponsor
- Boston Scientific Corporation
Obesity and Obesity-related Medical Conditions, Weight Loss
Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss
The objective of this study is to assess the long term weight loss and weight loss journey of patients who received an Endoscopic Sleeve Gastroplasty (ESG) 5 or more years prior to enrollment.
- Trial name
- LIGHT (NCT06894498)
- Testing
- No Intervention: Observational Cohort
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Boston Scientific Corporation
Persistent Atrial Fibrillation
Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation
The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial…
- Trial name
- AVANT GUARD (NCT06096337)
- Testing
- FARAPULSE™ Pulsed Field Ablation (PFA) System, Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone
- Where
- 61 sites in United States, Australia and 11 more
- Volunteers
- 484 people
- Sponsor
- Boston Scientific Corporation
Stroke
Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation
The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial…
- Trial name
- ASAP-TOO (NCT02928497)
- Testing
- WATCHMAN LAAC Device Implant, Single Antiplatelet Therapy or No Therapy (Control)
- Where
- 92 sites in United States, Belgium and 7 more
- Volunteers
- 481 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System
The goal of any novel design or therapeutic strategy to treat atrial fibrillation is to restore normal sinus rhythm and to reduce or eliminate the symptoms due to rapid atrial response.
- Trial name
- FARADISE (NCT05501873)
- Testing
- FARAPULSE Pulsed Field Ablation system
- Where
- 48 sites in Australia, Austria and 19 more
- Volunteers
- 1,173 people
- Sponsor
- Boston Scientific Corporation
Inoperable Hepatocellular Carcinoma
MANDARIN (S6371)
To evaluate the efficacy and safety of TheraSphereTM yttrium [90Y] glass microsphere in the Chinese patients with inoperable hepatocellular carcinoma.
- Trial name
- NCT05016245
- Testing
- TheraSphere™ Yttrium-90 Glass Microspheres, conventional Transarterial Chemoembolization(cTACE)
- Where
- China
- Volunteers
- 92 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
POLARx Post Approval Study (POLARx PAS)
To collect clinical data on safety, effectiveness and procedural success of Boston Scientific's Cardiac Cryoablation System (includes all BSC commercially available POLARx/POLARx Fit catheters) when used to perform pulmonary vein…
- Trial name
- NCT06170606
- Testing
- Boston Scientific Cardiac Cryoablation System
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Intraductal Papillary Mucinous Neoplasm
Intra-operative Pancreatoscopy in Patients With IPMN
To demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous…
- Trial name
- NCT03729453
- Testing
- SpyGlass
- Where
- 8 sites in United States, China and 4 more
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Obesity
RESCUE: Discontinuation of GLP-1
This study is designed to compare weight loss outcomes and safety of ESG versus lifestyle modification in patients with obesity who discontinued GLP-1 therapy due to intolerance or suboptimal weight loss.
- Trial name
- NCT07190794
- Testing
- OverStitch™ or OverStitch NXT™, Lifestyle Modification
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Boston Scientific Corporation
Chronic Pain
A DirEct to PatieNt Study in Chronic Pain
To compile real-world, direct from patient clinical outcomes and objective metrics in patients who have received or plan to receive a commercially approved interventional medical device therapy/procedure for chronic pain in…
- Trial name
- ENLITEN (NCT05515341)
- Testing
- Commercially Approved Interventional Medical Device/Therapy for Chronic Pain
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- Boston Scientific Corporation