Clinical trials: open to volunteers, sponsored by Boston Scientific Corporation
Anastomotic Leaks, Hartmanns Stump Leakage
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
This study is intended to evaluate the safety and effectiveness of Sponge-based Endoscopic Vacuum Therapy (EVT) using Endo-SPONGE for the treatment of Anastomotic Leaks (AL) or Hartmann's stump leakages following colorectal…
- Trial name
- DRAIN Lower (NCT07035431)
- Testing
- Endo-SPONGE
- Where
- 10 sites in United States
- Volunteers
- 66 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
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 - NYHA II - IV
Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure
This study will compare two different methods to pace the heart to treat heart failure including: 1. The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left…
- Trial name
- SYNCHRONICITY (NCT07069738)
- Testing
- CRT-D with a Quadripolar LV lead, CRT-D with INGEVITY+ pace/sense lead
- Where
- 43 sites in United States
- Volunteers
- 850 people
- Sponsor
- Boston Scientific Corporation
Cardiac Disease
BoStOn SCientific Rhythm MAnagemenT REgiStry
SOCRATES is part of Boston Scientific's (BSC) Post-market surveillance system. The implementation of such systems is mandatory per local regulations such as the Regulation '(EU) 2017/745 of the European Parliament and of the…
- Trial name
- SOCRATES (NCT04823663)
- Testing
- Implant, Electrophysiologic procedure
- Where
- 26 sites in Belgium, Canada and 8 more
- Volunteers
- 12,500 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
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
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
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
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
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
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
Cardiac Arrythmias
RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
The objective of the RHAPSODY study is to evaluate the performance of new software features in subjects undergoing standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial…
- Trial name
- RHAPSODY (NCT03053141)
- Testing
- Rhythmia Mapping System
- Where
- 8 sites in United States, Italy and 1 more
- Volunteers
- 100 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
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
Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PersAF)
A Global Randomized Trial Evaluating the FARAFLEX™ Mapping and Pulsed Field Ablation System With Electrographic Flow Mapping in Patients Undergoing Repeat Ablation for Atrial Fibrillation
The goal of the ReDEFINE-AF Clinical Study is to evaluate the safety and effectiveness of the FARAFLEX™ Mapping and Pulsed Field Ablation System with electrographic flow mapping in subjects undergoing repeat ablation for atrial…
- Conditions
- Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PersAF), Paroxysmal Atrial Fibrillation (PAF)
- Trial name
- ReDEFINE-AF (NCT07820930)
- Testing
- FARAFLEX Mapping and Pulsed Field Ablation System
- Volunteers
- 650 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Persistent Atrial Fibrillation
Feasibility Study of the FARAFLEX Mapping and PFA System
The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF) or…
- Conditions
- Atrial Fibrillation, Persistent Atrial Fibrillation, Paroxysmal AF
- Trial name
- ELEVATE-PF (NCT06510556)
- Testing
- FARAFLEX Ablation Treatment, ELEVATE-COR Sub-study
- Where
- 4 sites in Belgium, Croatia and 2 more
- Volunteers
- 250 people
- Sponsor
- Boston Scientific Corporation
Atrial Arrhythmia, Intracardiac Echocardiography
A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure
A first-in-human prospective data collection study including subjects who are planned to undergo an ablation procedure for any atrial arrhythmia as per medical judgement and the site's standard practice, represents the most…
- Trial name
- SONAR-ICE (NCT07353710)
- Testing
- ICE Image Acquisition
- Where
- 8 sites in Australia, Croatia and 6 more
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation