Clinical trials: medical devices
- Funder type Industry (pharma, biotech, devices)
- Type of treatment Medical devices
- Has posted results yes
Tricuspid Valve Regurgitation, Heart Valve Diseases
TRISCEND JAPAN Study
A prospective, open, non-randomized, multicenter, clinical trial to evaluate the safety and effectiveness of the Edwards EWJ-202 transcatheter tricuspid valve replacement system in the treatment of patients with at least severe…
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- TRISCEND JAPAN (NCT05760989)
- Testing
- Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System
- Where
- 8 sites in Japan
- Volunteers
- 53 people
- Sponsor
- Edwards Lifesciences
Postoperative Pain, Total Shoulder Arthroplasty
Cohort 1 (TSA) of: A Multi-surgery Assessment of ZYNRELEF (HTX-011)
Cohort 1 (subjects undergoing total shoulder arthroplasty, TSA) of a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical…
- Conditions
- Postoperative Pain, Total Shoulder Arthroplasty, Multimodal Analgesia
- Trial name
- AMAZE (NCT06109415)
- Testing
- HTX-011, Bupivacaine Hydrochloride, MMA regimen
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Heron Therapeutics
Colon Cancer, Colon Polyp
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
For patients with colon polyps (clumps of cells in the lining of the colon) treatment often requires removal of the affected portion of the colon.
- Conditions
- Colon Cancer, Colon Polyp, Diverticular Diseases, Inflammatory Bowel Diseases
- Trial name
- NCT04703829
- Testing
- VI-RASD use in minimally invasive right or left colectomy, Right or Left colectomy
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Virtual Incision Corporation
Postoperative Pain
PK and Safety After C-Section
The main goal of the study was to measure the amount of the active ingredients and other components of HTX-011 in plasma and expressed breast milk over time following postpartum administration in women undergoing a planned…
- Trial name
- NCT03955211
- Testing
- HTX-011, ZYNRELEF kit components for administration, MMA regimen
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Heron Therapeutics
Hemorrhage, Surgical, Blood Loss, Surgical
Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-Antithrombotic Removal (ATR) system for intraoperative removal of ticagrelor in patients undergoing urgent…
- Conditions
- Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative, Hemorrhage Postoperative
- Trial name
- STAR-T (NCT04976530)
- Testing
- DrugSorb-ATR system
- Where
- 29 sites in United States, Canada
- Volunteers
- 140 people
- Sponsor
- CytoSorbents, Inc
Colorectal Cancer, Polyp of Colon
EAGLE Trial CADDIE Artificial Intelligence Endoscopy
The EAGLE study is a prospective randomized controlled multicenter parallel design trial, for the assessment of clinical performance of the CADDIE device and to confirm that the device performs as expected.
- Conditions
- Colorectal Cancer, Polyp of Colon, Adenoma Colon
- Trial name
- EAGLE (NCT05730192)
- Testing
- Colonoscopy with CADDIE, Standard Colonoscopy
- Where
- 8 sites in Germany, Italy and 2 more
- Volunteers
- 985 people
- Sponsor
- Odin Medical
Advanced Cancer, Pancreatic Cancer Metastatic
Safety Study of Whole Body Hyperthermia for Advanced Cancer
Millions of patients die of cancer every year. There are several methods to treat cancer, including surgery, chemotherapy, radiotherapy and immunotherapy. Recently, hyperthermia therapy started playing a role in cancer therapy.
- Trial name
- MATTERS (NCT04467593)
- Testing
- Whole body hyperthermia, Standard of Care (SOC) chemotherapy according to the NCCN guidelines.
- Where
- Belgium
- Volunteers
- 16 people
- Sponsor
- ElmediX
Femoral Arteriotomy Closure
Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
This is an observational study designed to evaluate the safety and clinical outcomes of the MANTA® Vascular Closure Device (VCD) (the MANTA® Device) in TAVR procedures.
- Trial name
- ACCESS MANTA (NCT05936996)
- Testing
- MANTA Vascular Closure Device
- Where
- 10 sites in United States, Canada
- Volunteers
- 258 people
- Sponsor
- Essential Medical, Inc.
Spinal Duraplasty
Adherus™ Dural Sealant in Spinal Procedures
The purpose of this study is to test an experimental device, the Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant, in spinal surgical procedures.
- Trial name
- NCT04498026
- Testing
- Adherus Dural Sealant System, DuraSeal Exact Dural Sealant System
- Where
- 14 sites in United States
- Volunteers
- 94 people
- Sponsor
- Stryker Craniomaxillofacial
Peripheral Arterial Disease
Observational Study to Assess Transradial Access for Treatment in the Lower Extremities.
This study is designed to collect data on the complication rates and procedural success of using a transradial access approach to treat peripheral lesions in the lower extremities of a real world population.
- Trial name
- R2P Registry (NCT04371861)
- Testing
- Peripheral Artery Treatment
- Where
- 8 sites in United States
- Volunteers
- 120 people
- Sponsor
- Terumo Medical Corporation
Pregnancy, Fetal Monitoring
Use of In-Home Non-Stress Monitoring Device for Fetal Monitoring: A Nonsignificant Risk (NSR) Device Study
This study evaluates the safety and performance of the PregnaOne System, a non-significant risk (NSR) investigational medical device for in-home fetal monitoring in pregnant women during the third trimester.
- Trial name
- NCT07223996
- Testing
- PregnaOne System
- Where
- 3 sites in United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Nestmedic Spolka Akcyjna
Prosthesis User, Amputation
Connect TF - An Investigation of Function and Usability of a New Adaptable Socket System
The primary objective of this investigation is to evaluate how the CONNECT TF compares to traditional handmade sockets, specifically that it provides reliable suspension and improved usability and comfort for the amputee, and…
- Trial name
- NCT04388488
- Testing
- CONNECT TF adaptable socket system, Any conventional handmade socket
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Össur Iceland ehf
Urinary Incontinence
This Study Will Collect Clinical and Patient Reported Satisfaction Data From Males Requiring Urine Output Management Overnight in the Home Setting.
This post-market study will assess the performance of and user satisfaction with the PureWick® Male External Catheter in a home setting.
- Trial name
- PUREST-M (NCT06850259)
- Testing
- PureWick® Urine Collection System, UltraFlex™ Self-Adhering Male External Catheter
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- C. R. Bard
Hearing Loss
Nucleus Hybrid L24 Extended Duration Post Approval Study
This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid L24 Implant System in a group of already implanted recipients.
- Trial name
- HED (NCT02379273)
- Testing
- Nucleus Hybrid L24 Implant
- Volunteers
- 35 people
- Sponsor
- Cochlear
Prosthesis User
Efficacy of a Vented Liner and Socket System for Individuals With Trans-femoral Amputation
The objective of the investigation is to measure the humidity within a transfemoral amputee's prosthesis during physical activity in a pre-heated room, using both the vented AeroFit system and a non-vented comparator.
- Trial name
- NCT05279885
- Testing
- Vented suspension system, Non-vented suspension system
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Jóna Valgerður Kristjánsdóttir
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow…
- Conditions
- Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease
- Trial name
- NCT03130777
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
- Where
- 14 sites in United States
- Volunteers
- 86 people
- Sponsor
- Edwards Lifesciences
Coronary Restenosis
SELUTION SLR™ 014 In-stent Restenosis
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial. Subjects with previous bare-metal stent (BMS) or Drug-Eluting Stent (DES) and qualifying evidence for In-stent Restenosis (ISR) will…
- Trial name
- SELUTION4ISR (NCT04280029)
- Testing
- SELUTION SLR 014 DEB, Standard of Care
- Where
- 48 sites in United States, Belgium and 5 more
- Volunteers
- 418 people
- Sponsor
- M.A. Med Alliance S.A.
Brain Tumor
Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound
The purpose of this study is to evaluate the safety of BBB disruption using transcranial MRI-guided focused ultrasound in conjunction with an intravenous ultrasound contrast agent to increase the accumulation of doxorubicin in…
- Trial name
- NCT02343991
- Testing
- Transcranial ExABlate
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- InSightec
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
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
Study RIN-PF-303 is a multinational study designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.
- Trial name
- TETON-2 (NCT05255991)
- Testing
- Inhaled Treprostinil, Treprostinil Ultrasonic Nebulizer
- Where
- 108 sites in Argentina, Australia and 14 more
- Volunteers
- 597 people
- Sponsor
- United Therapeutics
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