Clinical trials: Implant Therapy
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
Breast Cancer
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy
This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.
- Trial name
- NCT01959867
- Testing
- SurgiMend® PRS, No Intervention
- Sponsor
- Integra LifeSciences Corporation
Nasal Valve Collapse
Validity Study of a Nasal Valve Implant
The purpose of this study is to determine if an implant material can be injected to repair nasal valve collapse.
- Trial name
- NCT00837525
- Testing
- nasal valve implant
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Nasoform, LLC
Infertility
Study to Estimate Seedchrony's Predictive Capacity in the Success of Embryo Implantation.
In Vitro Fertilization (IVF) success is below 40%, with Embryo Transfer the leading cause of IVF failure. This clinical investigation aims to evaluate if the levels of an intrauterine biomarker dissolved in the uterine fluid…
- Trial name
- Seedchrony02 (NCT06259084)
- Testing
- Seedchrony
- Where
- Spain
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Manina Medtech
Coronary Artery Disease, Myocardial Ischemia
The eSVS® Mesh Randomized Post-Market Study
The purpose of this study is to evaluate patency rates of the external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Grafts (SVG) and Control SVG at 3-6 months and 24 months.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases
- Trial name
- NCT01462721
- Testing
- eSVS® Mesh
- Where
- Germany
- Volunteers
- 12 people
- Sponsor
- Kips Bay Medical, Inc.
Coronary Artery Disease
TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent
The ultimate goal of a paclitaxel eluting stent system (TAXUS stent) is to prevent restenosis by blunting the initial response to stent implant injury and sustaining the arrested response until vascular healing has taken place.
- Trial name
- NCT00292474
- Testing
- percutaneous coronary intervention
- Where
- United States
- Volunteers
- 1,326 people
- Sponsor
- Boston Scientific Corporation
Fecal Incontinence
Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence
This is first-in-human prospective Phase I study of the immediate and long-term safety of an implanted internal anal sphincter (IAS) bioengineered from autologous cells to treat subjects with severe passive FI who have failed…
- Trial name
- NCT05616208
- Testing
- Bioengineered Internal Anal Sphincter
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cellf Bio LLC
Congestive Heart Failure (CHF)
Clinical Evaluation of Cardiac Resynchronization Therapy (CRT) Using the Ovatio CRT Implantable Cardioverter-defibrillator (ICD) System
This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by helping the left ventricle contract (pump…
- Trial name
- NCT00528320
- Testing
- Ovatio CRT
- Sponsor
- ELA Medical, Inc.
Bone Conduction, Hearing Loss, Conductive
Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
The goal of this interventional study is to confirm the safety and performance of the latest generation Osia System and to examine its benefits compared to the Baha Connect System in adults with mixed or conductive hearing loss…
- Conditions
- Bone Conduction, Hearing Loss, Conductive, Hearing Loss, Mixed
- Trial name
- OSIRIS (NCT07130136)
- Testing
- Cochlear™ Osia® System, Cochlear™ Baha® System
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Cochlear
Heart Failure, Heart Failure With Preserved Ejection Fraction
Assessment of CCM in HF With Higher Ejection Fraction
The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.
- Conditions
- Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Heart Failure With Moderately Reduced Ejection Fraction
- Trial name
- AIM HIGHer (NCT05064709)
- Testing
- Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System, OPTIMIZER™ Smart Mini System
- Where
- 67 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Impulse Dynamics
Anal Fistula
Ligation of the Intersphincteric Fistula Tract (LIFT) + Biodesign for Anal Fistula
The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of fistula closure in patients with persistent trans-sphincteric anal fistula who receive the Biodesign® Tissue graft as part of their LIFT…
- Trial name
- LIFT+Graft (NCT01602081)
- Testing
- reinforce soft tissue
- Where
- 8 sites in United States
- Volunteers
- 28 people
- Sponsor
- Cook Group Incorporated
Tricuspid Regurgitation Functional
Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System
An early feasibility study to evaluate the safety and performance of 1) the transcatheter delivery and implantation of the Cardiac Implants (CI) annuloplasty ring and 2) the adjustment of the ring approximately 90 days following…
- Trial name
- NCT04890821
- Testing
- CI Percutaneous Ring Annuloplasty System
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Cardiac Implants LLC
Magnetic Resonance Imaging
ENABLE MRI (Magnetic Resonance Imaging)
The objective of this study is to collect data to confirm the safety and effectiveness of the Image Ready™ MR (Magnetic Resonance) Conditional Defibrillation System when used in the 1.5T (Tesla) MRI environment under the labeled…
- Trial name
- ENABLE-MRI (NCT02652481)
- Testing
- ImageReady MR Conditional Defibrillation System
- Where
- 57 sites in United States, Belgium and 7 more
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Glaucoma, Glaucoma, Open Angle
SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma
Study Objective: To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP)…
- Trial name
- NCT00382395
- Testing
- SOLX Gold Shunt GMS-plus, Ahmed FP7 Glaucoma Valve
- Where
- 15 sites in United States, Canada and 3 more
- Volunteers
- 180 people
- Sponsor
- SOLX, Inc.
Diabetic Macular Edema
Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema
This was a multi-center, randomized, masked, parallel-group, controlled study in patients with diabetic macular edema, comparing RetisertTM (0.59 mg) with control therapy (standard of care (SOC) - repeat macular grid laser or…
- Trial name
- NCT00502541
- Testing
- fluocinolone acetonide, Standard of Care
- Volunteers
- 196 people
- Sponsor
- Bausch & Lomb Incorporated
Ventricular Tachycardia, Ischemic
Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators
The purpose of this study is to determine if early ablation (i.e., ablation of ventricular tachycardia in patients with infrequent VT episodes) is more effective than medical therapy alone for the treatment of ischemic…
- Trial name
- ASPIRE (NCT01557842)
- Testing
- Drug Treatment, Catheter Ablation
- Where
- 23 sites in United States
- Volunteers
- 15 people
- Sponsor
- Biosense Webster, Inc.
Urinary Bladder, Overactive
FemPulse Therapy for Overactive Bladder in Women
The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.
- Trial name
- EVANESCE-OAB (NCT03784170)
- Testing
- FemPulse System
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- FemPulse Corporation
COPD, Emphysema
A Trial of the Implantable Artificial Bronchus 50 Flex in Patients With Severe Emphysema
A Study at Two Hospitals Testing the Safety and Effectiveness of the IAB 50 Flex, a New Implant for Adults with Severe COPD or Emphysema
- Trial name
- IAB-3 (NCT07086339)
- Testing
- Implantable pulmonary stent
- Where
- 2 sites in France, Netherlands
- Volunteers
- 20 people
- Sponsor
- Pulmair Medical, Inc.
Urinary Incontinence
An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
This clinical trial is being conducted to investigate the safety and effectiveness of a new device designed to treat urinary urge incontinence in those patients who have tried and failed two or more conservative therapies.
- Trial name
- NCT00080470
- Testing
- bion
- Where
- 11 sites in United States
- Volunteers
- 148 people
- Sponsor
- Boston Scientific Corporation
Arterial Occlusive Disease, Intermittent Claudication
Safety and Efficacy of Express LD to Treat Stenosed or Occlusive Atherosclerotic Disease in Iliac Arteries
To obtain additional data on safety and efficacy of the Express stent implantation in the treatment of stenosed or occlusive atherosclerotic disease (de novo or restenotic lesions) in the iliac arteries (common or external).
- Conditions
- Arterial Occlusive Disease, Intermittent Claudication, Atherosclerotic Disease, Thrombosis
- Trial name
- MELODIE (NCT00352222)
- Testing
- stent implantation
- Where
- 10 sites in Belgium, Canada and 3 more
- Volunteers
- 150 people
- Sponsor
- Boston Scientific Corporation