Clinical trials: Implant Therapy
Cartilage or Osteochondral Defects in the Knee
COPLA® Cartilage Implant Pilot Clinical Trial
This is a first-in-human clinical, open label, non-randomized, prospective investigation to assess the initial safety and performance of the COPLA® cartilage implant.
- Trial name
- NCT05685316
- Testing
- COPLA® cartilage implant
- Where
- 6 sites in Estonia, Finland and 1 more
- Volunteers
- 20 people
- Sponsor
- Askel Healthcare Ltd
Atrial Fibrillation
Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
There are insufficient data on the safety and efficacy of edoxaban plus antiplatelet therapy in subjects with atrial fibrillation (AF) following percutaneous intervention (PCI) with stenting.
- Trial name
- ENTRUST-AF-PCI (NCT02866175)
- Testing
- Edoxaban, Clopidogrel, Prasugrel
- Where
- 200 sites in Austria, Belgium and 16 more
- Volunteers
- 1,506 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Heart Failure
REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- NCT00271154
- Testing
- Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT
- Where
- 65 sites in United States, Austria and 13 more
- Volunteers
- 684 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Fibrillation, Ventricular Tachycardia
Remote Follow-up of Patients Receiving Implantable Cardioverter Defibrillator for Prophylactic Therapy
The completed MADIT II study has shown that implantation of a cardioverter-defibrillator (ICD) in patients with a reduced left ventricular ejection fraction and a prior myocardial infarction reduces death from any cause.
- Trial name
- REFORM (NCT00401466)
- Testing
- Implantable Cardioverter Defibrillator
- Where
- 5 sites in Czechia, Germany
- Volunteers
- 155 people
- Sponsor
- Biotronik SE & Co. KG
Chronic Pain, Intractable Pain
Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy
The PERSIST study is being conducted within Medtronic's active post-market surveillance platform, the Product Surveillance Registry (PSR).
- Trial name
- PERSIST (NCT07507422)
- Testing
- Commercially available Inceptiv™ neurostimulation systems
- Where
- 10 sites in United States, France and 1 more
- Volunteers
- 970 people
- Sponsor
- Medtronic
Repetitive Implantation Failure
ERA Test in Patients With Recurrent Implantation Failure
The purpose of this study is to demonstrate the clinical efficiency of the Endometrial Receptivity Array (ERA) diagnostic tool in patients with repetitive implantation failure (RIF), leading to the new concept of the personalized…
- Trial name
- ERA (NCT01668693)
- Testing
- ERA (Endometrial Receptivity Array), Personalized Embryo Transfer, Second ERA
- Where
- Spain
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Igenomix
Discogenic Low Back Pain
PerQdisc Traditional Feasibility Trial.
This is a traditional feasibility study (TFS) study to evaluate the safety and effectiveness of the PerQdisc. The study is prospective, multicenter, and open label.
- Trial name
- NCT06860867
- Testing
- PerQdisc
- Where
- 8 sites in United States
- Volunteers
- 5 people
- Sponsor
- Spinal Stabilization Technologies
Obstructive Sleep Apnea of Adult
An Extension Study to Assess the Long-term Safety of the Genio® System
The objective of this study is to assess the long-term safety of the Genio® system in adult OSA patients with and without complete concentric collapse of the soft palate who have successfully been implanted with the Genio IS in a…
- Trial name
- OLE (NCT05939141)
- Testing
- Genio System
- Where
- 7 sites in Australia
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Nyxoah S.A.
Erectile Dysfunction Following Radical Prostatectomy
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction
The goal of this clinical trial is to assess if a new device is safe to use as a potential treatment for erectile dysfunction following radical prostatectomy.
- Trial name
- NCT05650866
- Testing
- Activation of pro-erectile nerves within the pelvic plexus
- Where
- 4 sites in Australia
- Volunteers
- 20 people
- Sponsor
- Comphya Australia
Monomorphic Ventricular Tachycardia
Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.
The intent of this observational study is to understand the role of non-invasive programmed stimulation (NIPS) to induce substrate based MMVT (Monomorphic Ventricular Tachycardia) in patients receiving new St.
- Trial name
- EPIC (NCT02584595)
- Testing
- ICD/CRT-D with NIPS or EP Study
- Sponsor
- Abbott Medical Devices
Rotator Cuff Injuries
Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and…
- Trial name
- IMPACT (NCT05444465)
- Testing
- Isolated Bioinductive Repair, Completion and Repair
- Where
- 20 sites in United States, Australia and 4 more
- Volunteers
- 234 people
- Sponsor
- Smith & Nephew, Inc.
Glaucoma, Open-Angle
Early Evaluation of the Beacon Aqueous Microshunt in Patients Refractory to Drug Therapy in the European Union
This is prospective, non-randomized, single-arm study to assess the safety and effectiveness of lowering intraocular pressure with the Beacon Aqueous Microshunt. A total of 65 subjects will be enrolled at five centers.
- Trial name
- EARLY BIRD EU (NCT03634319)
- Testing
- Beacon Aqueous Microshunt
- Where
- 2 sites in Germany
- Volunteers
- 10 people
- Sponsor
- MicroOptx
Cataract Senile
Precisight® Intraocular Lens Implantation for Cataract Treatment
The purpose of this study is to determine the refractive outcomes and optimize the clinical features of a new intraocular lens intended to treat the senile cataract.
- Trial name
- PEACE (NCT02970487)
- Testing
- Intraocular implant of the Precisight
- Where
- Philippines
- Volunteers
- 96 people
- Sponsor
- InfiniteVision Optics
Coronary Artery Disease
A Randomized, Double-blind Study to Assess Paclitaxel-eluting Stents in Treatment of Longer Lesions
The clinical investigation is an international, prospective, multi-center, double-blind, randomized safety and efficacy trial. The purpose of this study is to evaluate the safety and effectiveness of the TAXUS(TM)Stent System…
- Trial name
- TAXUS VI (NCT00297804)
- Testing
- TAXUS Express Paclitaxel-Eluting Coronary Stent System, Control stent
- Where
- Germany
- Volunteers
- 448 people
- Sponsor
- Boston Scientific Corporation
Presbyopia
Clinical Outcomes of Femtosecond Laser Presbyopia Treatment in Monofocal IOLs
This study aimed to assess the safety and efficacy of treating presbyopia in eyes implanted with a mono focal IOL using a low-energy femtosecond laser.
- Trial name
- NCT07384182
- Testing
- Perfector
- Where
- Czechia
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Perfect Lens, LLC
Atrial Fibrillation, Atrial Flutter
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Embolism, Systemic Arterial
- Trial name
- IMPACT (NCT00559988)
- Testing
- Home Monitoring Guided OAC, Physician-Directed OAC
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,718 people
- Sponsor
- Biotronik, Inc.
COPD Patients With Homogeneous Emphysema, Endoscopic Lung Volume Reduction With Endobronchial Valve
Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study
The aim of this prospective, randomized, controlled, one-way crossover study is to assess and compare the efficacy of the Zephyr endobronchial valves vs.
- Trial name
- IMPACT (NCT02025205)
- Testing
- Endobronchial Valve
- Where
- 8 sites in Austria, Germany and 1 more
- Volunteers
- 93 people
- Sponsor
- Pulmonx International Sàrl
Heart Failure
Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants
The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants.
- Trial name
- NCT01519739
- Testing
- MediGuide™
- Volunteers
- 15 people
- Sponsor
- Abbott Medical Devices
Chondral or Osteochondral Lesion of Medial Femoral Condyle, Chondral or Osteochondral Lesion of Lateral Femoral Condyle
BiPhasic Cartilage Repair Implant (BiCRI) IDE Clinical Trial - Taiwan
The purpose of this trial is to evaluate the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI) compared to marrow stimulation in the treatment of chondral and osteochondral lesions located on the medial…
- Conditions
- Chondral or Osteochondral Lesion of Medial Femoral Condyle, Chondral or Osteochondral Lesion of Lateral Femoral Condyle, Chondral or Osteochondral Lesion of Trochlea
- Trial name
- NCT01477008
- Testing
- BiPhasic Cartilage Repair Implant, Marrow Stimulation
- Where
- 11 sites in Taiwan
- Volunteers
- 92 people
- Sponsor
- BioGend Therapeutics Co.Ltd
Endometriosis
Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis
This study aims to evaluate the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.
- Trial name
- NCT06543550
- Testing
- Implantable gestrinone, Oral Dienogest
- Where
- 4 sites in Brazil
- Volunteers
- 70 people
- Sponsor
- Bio Meds Pharmaceutica Ltda