Clinical trials: sponsored by Boston Scientific Corporation
Atrial Fibrillation (AF), Stroke
Elite AF IDE Trial (Elite AF)
The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN Elite Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation who are eligible for…
- Trial name
- NCT07287436
- Testing
- WATCHMAN Elite LAAC Device
- Where
- 2 sites in United States
- Volunteers
- 400 people
- Sponsor
- Boston Scientific Corporation
Tachycardia, Ventricular, Arrhythmia, Ventricular
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.
- Trial name
- MODULAR ATP (NCT04798768)
- Testing
- mCRM Therapy System
- Where
- 38 sites in United States, Austria and 7 more
- Volunteers
- 297 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Stroke
CHAMPION-AF Clinical Trial
The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial…
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Trial name
- CHAMPION-AF (NCT04394546)
- Testing
- WATCHMAN FLX LAAC Device, Non-Vitamin K Oral Anticoagulant
- Where
- 141 sites in United States, Australia and 14 more
- Volunteers
- 3,000 people
- Sponsor
- Boston Scientific Corporation
Respiration Rate Detection
Respiration Measured Via End-tidal CO2 and Spirometry Study (RESPI)
To collect respiration data via end-tidal CO2 and spirometry and compare respiration rates measured via the two methods.
- Trial name
- RESPI (NCT07537478)
- Testing
- Wearable Respiration mask - exercise, Wearable respiration Mask
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Boston Scientific Corporation
Orthostatic Hypotension, Reflex Syncope
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
To characterize the impact of orthostatic hypotension (OH) and Vasovagal syncope on signals measured using a wearable Holter monitor in the clinic and ambulatory setting.
- Trial name
- ARISE (NCT07502599)
- Testing
- Wearable holter monitor
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
Essential Tremor
Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET)
To compile characteristics of real-world outcomes for Boston Scientific Corporation's commercially approved Deep Brain Stimulation (DBS) Systems, when used according to the applicable Directions for Use, for the treatment of…
- Trial name
- NCT04032470
- Testing
- Deep Brain Stimulation Systems (DBS)
- Where
- 20 sites in Austria, Belgium and 7 more
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Parkinson Disease, Dystonia
Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System - RAPID for CNS
The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.
- Conditions
- Parkinson Disease, Dystonia, Essential Tremor, Movement Disorders
- Trial name
- NCT06553625
- Testing
- Radiofrequency Ablation
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Dystonia
Vercise™ DBS Dystonia Prospective Study
To compile characteristics of real-world outcomes of Boston Scientific Corporation's commercially approved VerciseTM Deep Brain Stimulation (DBS) Systems for the treatment of dystonia.
- Trial name
- NCT02686125
- Testing
- Deep Brain Stimulation (DBS)
- Where
- 36 sites in Belgium, Canada and 10 more
- Volunteers
- 300 people
- Sponsor
- Boston Scientific Corporation
Pain
RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Instructions for Use and…
- Trial name
- RELIEF (NCT01719055)
- Testing
- neurostimulation system
- Where
- 118 sites in United States, Argentina and 14 more
- Volunteers
- 4,800 people
- Sponsor
- Boston Scientific Corporation
Benign Prostatic Hyperplasia (BPH)
REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men
The study objective is to compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men.
- Trial name
- VAPEUR (NCT04838769)
- Testing
- REZŪM, alpha blocker and 5-alpha reductase inhibitor
- Where
- 21 sites in Australia, France
- Volunteers
- 155 people
- Sponsor
- Boston Scientific Corporation
Parkinson's Disease
Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS System in the treatment of Parkinson's disease.
- Trial name
- NCT02071134
- Testing
- Deep Brain Stimulation (DBS)
- Where
- 87 sites in United States, Argentina and 13 more
- Volunteers
- 1,500 people
- Sponsor
- Boston Scientific Corporation
Weight Regain, Weight Loss
Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass
The goal of this clinical trial is to evaluate weight loss with TORe and moderate to intensive lifestyle modification versus moderate to intensive lifestyle modification alone in subjects who have regained weight following a…
- Trial name
- REIGNITE (NCT07015424)
- Testing
- TORe with OverStitch, Intensive lifestyle modification
- Where
- 12 sites in United States
- Volunteers
- 108 people
- Sponsor
- Boston Scientific Corporation
Prostate Cancer
Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer
To demonstrate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in subjects undergoing Stereotactic Body Radiotherapy (SBRT) to treat prostate cancer.
- Trial name
- SABRE (NCT04905069)
- Testing
- SpaceOAR Vue System
- Where
- 30 sites in United States, Australia and 7 more
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Benign Prostate Hypertrophy(BPH), Renal Calculi
Stone and Laser Therapies Post-Market Study (SALT)
The objective of the SALT Study is to obtain post-market safety and device performance data for Boston Scientific's Stone and BPH study devices used during a diagnostic and/or therapeutic urinary tract procedure (e.g.…
- Conditions
- Benign Prostate Hypertrophy(BPH), Renal Calculi, Ureteral Stones, Kidney Stones, Calculi, Urinary
- Trial name
- SALT (NCT06982235)
- Testing
- Ureteroscope system, Laser system
- Where
- 5 sites in United States
- Volunteers
- 238 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Stroke
SIMPLAAFY Clinical Trial
The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting.
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Trial name
- SIMPLAAFY (NCT06521463)
- Testing
- WATCHMAN FLX Pro LAAC Device
- Where
- 86 sites in United States
- Volunteers
- 1,857 people
- Sponsor
- Boston Scientific Corporation
Chronic Pain, Intractable Pain
Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control
Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU).
- Conditions
- Chronic Pain, Intractable Pain, Low Back Pain, Chronic Low-back Pain
- Trial name
- MOSAIC (NCT07190807)
- Testing
- Boston Scientific WaveWriter Alpha™ SCS Systems
- Where
- 7 sites in United States
- Volunteers
- 70 people
- Sponsor
- Boston Scientific Corporation
Prostate Cancer
SpaceIT Hydrogel System for Perirectal Spacing
To evaluate the safety and effectiveness of the SpaceIT™ Hydrogel System in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer.
- Trial name
- HYDROSPACE (NCT06451614)
- Testing
- SpaceIT Hydrogel System, Commercially available Boston Scientific Spacer
- Where
- 26 sites in United States, Canada
- Volunteers
- 230 people
- Sponsor
- Boston Scientific Corporation
Erectile Dysfunction
IT Matters: The Erectile Restoration Registry
The objective of the It MATTERS registry is to collect Real-World Data (RWD) to monitor the safe and effective use of commercially available Boston Scientific Corporation (BSC) penile prostheses
- Trial name
- NCT04200937
- Testing
- Tactra Malleable, Spectra™ Concealable Penile Prothesis, AMS Ambicor™ Inflatable Penile Prosthesis
- Where
- 25 sites in United States, China and 1 more
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Chronic Low-back Pain, Vertebrogenic Pain Syndrome
Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain
Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.
- Trial name
- IMPROVE (NCT06827262)
- Testing
- Intracept™ Intraosseous Nerve Ablation
- Where
- 22 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Boston Scientific Corporation
Chronic Pain
Paresthesia-Free Fast-Acting Subperception (FAST) Study
Study to evaluate the effectiveness of FAST-SCS (fast-acting paresthesia-free therapy) and additional SCS therapy options in patients with chronic pain using Boston Scientific WaveWriter SCS Systems.
- Trial name
- FAST (NCT04618471)
- Testing
- Boston Scientific WaveWriter SCS System
- Where
- 13 sites in United States
- Volunteers
- 177 people
- Sponsor
- Boston Scientific Corporation