Clinical trials: Medical Device
Overactive Bladder (OAB)
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)
A study to evaluate the safety and effectiveness of FemPulse System
- Trial name
- EVANESCE-II (NCT07195656)
- Testing
- Device Group, Medication Group
- Where
- 15 sites in United States
- Volunteers
- 151 people
- Sponsor
- FemPulse Corporation
Migraine
Acute Treatment of Migraine With e-TNS
The main objective of this study is to assess the efficacy of the Cefaly® device as an acute treatment of migraine attack in adult patients.
- Trial name
- ACME (NCT02590939)
- Testing
- CEFALY Active
- Where
- 3 sites in United States
- Volunteers
- 106 people
- Sponsor
- Cefaly Technology
Anterior Cruciate Ligament Reconstruction
Iovera° to Treat Pain Associated With ACL Reconstruction and Rehabilitation
To evaluate the outcomes of patients undergoing iovera° treatment of the ISN and AFCN on postoperative knee pain and function following anterior cruciate ligament reconstruction
- Trial name
- NCT03688477
- Testing
- iovera°
- Where
- United States
- Sponsor
- Pacira Pharmaceuticals, Inc
Glaucoma
Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound With the EYEOP Medical Device
The aim of the study is to evaluate the effectiveness and the safety of the EYEOP treatment using High Intensity Focused Ultrasound in refractory glaucoma patients.
- Trial name
- NCT01338467
- Testing
- EYEOP device
- Where
- 9 sites in France
- Volunteers
- 52 people
- Sponsor
- EyeTechCare
Overweight or Obesity
Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21®
The present clinical investigation is a randomized, double-blinded, placebo-controlled, multicenter international trial, planned to be conducted in Poland, Romania and Slovakia.
- Trial name
- SHINE (NCT06087822)
- Testing
- IMD SiPore21®
- Where
- 27 sites in Poland, Romania and 1 more
- Volunteers
- 318 people
- Sponsor
- Sigrid Therapeutics AB
Hypertension
Device Based Therapy in Hypertension Extension Trial
This clinical investigation is designed to describe the long-term safety and efficacy of the CVRx Rheos Baroreflex Hypertension Therapy System in patients who participated in the DEBuT-HT study beyond the original follow up…
- Trial name
- DEBuT-HET (NCT00710294)
- Testing
- CVRx Rheos Baroreflex Hypertension Therapy System
- Where
- 5 sites in Germany, Netherlands and 1 more
- Volunteers
- 50 people
- Sponsor
- CVRx, Inc.
Heart Failure
Remote Monitoring and Optimization of Heart Failure Therapy
Heart failure is a condition in which the heart cannot pump blood effectively, often leading to symptoms such as shortness of breath and fluid retention.
- Trial name
- REMODEL-HF (NCT07622472)
- Testing
- Wearable Monitoring Device for Heart Failure
- Where
- 9 sites in France, Germany and 7 more
- Volunteers
- 800 people
- Sponsor
- Zoll Medical Corporation
Cervical Cancer
Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer
The purpose of this study is to evaluate the safety, performance and usability of the Xoft Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the physician's current standard treatment practice…
- Trial name
- NCT01851772
- Testing
- Treatment with Electronic Brachytherapy
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Xoft, Inc.
Fecal Incontinence
Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.
- Trial name
- TRANSFORM (NCT01090739)
- Testing
- TOPAS Treatment for Fecal Incontinence
- Where
- 14 sites in United States
- Volunteers
- 207 people
- Sponsor
- ASTORA Women's Health
Safety and Tolerability in Healthy Subjects
BACK4 Safety Evaluation
To characterize the safety of combined RF and EMS therapies with the BACK4 device in healthy volunteers. Subjects will receive 3 treatments of increasing intensity over a one week period.
- Trial name
- NCT07153900
- Testing
- Treatment with BACK4 System
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- SWIMS America Corp.
Cardiac Arrhythmia
Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in PatientS Wearing a Novel Device With Biometric Based Medications Changes
To determine the associations among biometric data and previously reported medication changes in the original MAPS study
- Trial name
- MAPS II (NCT05505136)
- Testing
- Arrhythmia Management System (AMS)
- Where
- 8 sites in United States
- Volunteers
- 62 people
- Sponsor
- Zoll Medical Corporation
Cataract
DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus
A comparison of the ability of DisCoVisc to that of other ophthalmic viscosurgical devices (OVDs) (DuoVisc, Healon5 or Amvisc PLUS) regarding endothelial protection and anterior chamber space maintenance during non-eventful…
- Trial name
- NCT00712244
- Testing
- DisCoVisc, DuoVisc, Healon5
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- Alcon Research
Sternum Wound Infection, Nonunion of Fracture of Sternum
Sternal Closure With STERNUMFIX in Patients With High Risk
The primary objective is to establish if the SternumFix System improves sternal closure. The study should test the hypothesis that in a high risk patient population with increased risk for the development of sternal wound…
- Trial name
- STEPHIX (NCT01408745)
- Testing
- Sternumfix, steel wire
- Where
- 4 sites in Germany, Switzerland
- Volunteers
- 166 people
- Sponsor
- Aesculap AG
Stroke
Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes
This study aims to evaluate the impact of the Neurolutions Upper Extremity Rehabilitation System, known as IpsiHand, on improving functional motor control for post-stroke patients with hemiparesis.
- Trial name
- NCT04338971
- Testing
- IpsiHand Therapy
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Neurolutions, Inc.
Skin Texture Disorder, Photoaging
Safety and Efficacy Evaluation of the Mosaic Ultra Device
Evaluate the Safety and Efficacy of the Mosaic Ultra 1550nm system for the treatment of skin tone and texture, facial rejuvenation, photoaging, wrinkles, scars, stretch marks, acne vulgaris and hair loss.
- Conditions
- Skin Texture Disorder, Photoaging, Wrinkle, Scar
- Trial name
- NCT06117293
- Testing
- Mosaic
- Where
- 3 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- CynosureLutronic
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
Healthy Men and Women
Open-label Study Using 50 Mg Liquid Etanercept Subcutaneous Injection in the Thigh to Compare an Auto-injector Device and a Manual Injection in Healthy Subjects
A single-center, open-label, randomized study with a screening period of up to 21 days. Following that, eligible men and women will receive 50 mg of etanercept subcutaneously in the thigh to compare injection by auto-injection…
- Trial name
- NCT02588534
- Testing
- etanercept (ENBREL®) via auto-injector device, Etanercept (ENBREL®) via Manual injection
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Amgen
Tibial Delayed Healing
Tibial Delayed Healing Pivotal Clinical Trial
Evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to autograft in the treatment of tibial delayed healing.
- Trial name
- NCT01016067
- Testing
- INFUSE/MASTERGRAFT, Autograft bone
- Where
- 16 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Medtronic Spinal and Biologics
Critical Limb Ischemia (CLI)
Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease.
- Trial name
- VITAL-IT 1 (NCT07006467)
- Testing
- Implantation of RFS
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Stentit
Perfusion; Complications, Wound; Foot
Avazzia-University of Texas Southwestern Medical Center-Tennant Biomodulator® PRO Perfusion Study
This study is an open label trial designed to test the effectiveness of the Tennant Biomodulator® PRO electrical stimulation device (Avazzia), which uses BEST™ (Bio-Electric Stimulation Technology), on hospital in-patients to…
- Trial name
- NCT03843307
- Testing
- Avazzia Tennant Biomodulator® PRO
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Avazzia, Inc