Clinical trials: Implants
Coronary Artery Disease
ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients
This is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption (IDE) study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in St Jude Medical ICD…
- Trial name
- AnalyzeST (NCT01424722)
- Testing
- Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices
- Where
- 97 sites in United States
- Volunteers
- 2,258 people
- Sponsor
- Abbott Medical Devices
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
Glaucoma
Early Feasibility Study of the Brown Glaucoma Implant in Patients With Severe Visual Impairment or No Light Perceived
This is a prospective, non-randomized, single-arm early feasibility study to assess the safety and feasibility of lowering intraocular pressure with the Brown Glaucoma Implant.
- Trial name
- Early Bird (NCT03469297)
- Testing
- Brown Glaucoma Implant
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- MicroOptx
Hearing Loss, Sensorineural
Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults
The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor
- Trial name
- SME (NCT03007472)
- Testing
- CI532, Nucleus 7
- Where
- 10 sites in United States
- Volunteers
- 96 people
- Sponsor
- Cochlear
Left Sided Heart Failure
HW006 LATERAL Thoracotomy
This is a prospective, multi-center,single-arm study that will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD System and enrolled in the Interagency Registry for…
- Trial name
- HVAD (NCT02268942)
- Testing
- HeartWare HVAD, Thoracotomy
- Where
- 26 sites in United States, Canada
- Volunteers
- 144 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Knee Osteoarthritis
A Study to Compare the Press Fit Condylar (P.F.C.) Sigma Rotating-platform High-flexion (RP-F) Versus the Press Fit Condylar (P.F.C.) Sigma Rotating-platform (RP) Knee Implants
The main objective of this study is to determine if the P.F.C. Sigma RP-F Knee delivers a greater post-operative range of motion (ROM) compared with the P.F.C. Sigma RP Knee in primary TKA.
- Trial name
- NCT00733369
- Testing
- PFC Sigma RP-F, PFC Sigma RP
- Where
- 2 sites in Spain, United Kingdom
- Volunteers
- 106 people
- Sponsor
- DePuy International
Glaucoma, Glaucoma, Open Angle
AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma
To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with refractory glaucoma.
- Trial name
- NCT02036541
- Testing
- AqueSys XEN 45 Glaucoma Implant
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- AqueSys, Inc.
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.
Macular Telangiectasia Type 2
Safety Study to Evaluate Bilateral CNTF Implants in Subjects With MacTel Type 2
This is a multi-center, open-label, 6-month study to evaluate the safety of bilateral CNTF implants in participants with Macular Telangiectasia Type 2.
- Trial name
- NCT04729972
- Testing
- NT-501 CNTF implant
- Where
- 10 sites in United States, Australia
- Volunteers
- 33 people
- Sponsor
- Neurotech Pharmaceuticals
Dental Implants
Multicenter Retrospective Study Evaluating ATLANTIS™ Abutment Teeth Connected to Implants
The study is designed as a retrospective and multi-center study. The study population is US individuals previously restored with titanium and gold-shaded titanium ATLANTIS abutments.
- Trial name
- NCT02496091
- Testing
- ATLANTIS Abutment
- Where
- 6 sites in United States
- Volunteers
- 144 people
- Sponsor
- Dentsply Sirona Implants and Consumables
Sensorineural Hearing Loss, Bilateral
An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.
- Trial name
- NCT03904420
- Testing
- Clinical Education and Treatment Model, Traditional Model
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Cochlear
Presbyopia
Safety and Effectiveness of the AcuFocus Corneal Inlay ACI7000PDT in Presbyopes
The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will provide an effective method of for the correction of presbyopia in patients who have normal distance vision but need correction such as…
- Trial name
- NCT01352442
- Testing
- AcuFocus Corneal Inlay ACI 7000PDT
- Where
- 11 sites in Australia, Austria and 8 more
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- AcuFocus, Inc.
Retinitis Pigmentosa, Usher Syndrome Type 2
Retinal Imaging in CNTF -Releasing Encapsulated Cell Implant Treated Patients for Early-stage Retinitis Pigmentosa
This clinical trial is a single-site, 30 patient study for participants who have early stage retinitis pigmentosa, or Usher syndrome (type 2 or 3). Funding Source - FDA OOPD and Foundation Fighting Blindness.
- Conditions
- Retinitis Pigmentosa, Usher Syndrome Type 2, Usher Syndrome Type 3
- Trial name
- NCT01530659
- Testing
- NT-501
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Neurotech Pharmaceuticals
Heart Failure
C-Pulse IDE Feasibility Study- A Heart Assist System
The C-Pulse Feasibility Study is evaluating the safety and performance of a new product for the treatment of heart failure. The product is designed to help reduce the symptoms of heart failure and help patients function better…
- Trial name
- NCT00815880
- Testing
- C-Pulse™ (Implantable Counterpulsation Therapy)
- Where
- 6 sites in United States
- Volunteers
- 21 people
- Sponsor
- Nuwellis, Inc.
Dental Prophylaxis and Implant Surgery
Antimicrobial Agent for Reducing Bacteria in Aerosols and Oral Cavity
The primary objective of this study will be to evaluate the effect of two week pre-surgical rinsing with an antimicrobial mouthrinse containing 0.2% w/v Chlorhexidine digluconate on the total number of plaque bacteria in the…
- Trial name
- NCT02319668
- Testing
- 0.2% w/v Chlorhexidine digluconate, Sodium fluoride toothpaste (Aquafresh Mild & Minty)
- Where
- United Kingdom
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Patient and Surgical Related Risk Factors for Complications
TiLoop® Bra for Breast Reconstruction
A new approach for single stage implant based breast reconstruction (BR) is the use of a titanium-coated polypropylene mesh (TCPM) as an alternative to acellular dermal matrix (ADM).
- Trial name
- NCT01544023
- Volunteers
- 207 people
- Sponsor
- University of Rostock
Glaucoma, Cataract
Ologen (OculusGen)-Phacotrabeculectomy Historical Control Study in India
1. . Study Objective: The objective of this study is to determine the safety and effectiveness of the OculusGenTM Biodegradable Collagen Matrix Implant in phacotrabeculectomy surgery.
- Trial name
- NCT00477685
- Testing
- OculusGen Biodegradable Collagen Matrix Implant
- Where
- India
- Volunteers
- 10 people
- Sponsor
- Pro Top & Mediking Company Limited
Sensorineural Hearing Loss
Esteem New Subject Enrollment Post Approval Study
The New Enrollment Post-Approval Study is designed to evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from moderate to severe hearing loss.
- Trial name
- NCT02689349
- Testing
- Implantation of Esteem
- Where
- 6 sites in United States
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- Envoy Medical Corporation
Cataract, Corneal Astigmatism
Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL
This is a multicenter, prospective, single-arm, open-label, clinical study of the commercially available TECNIS Toric II, Model ZCU IOL.
- Trial name
- NCT04210232
- Testing
- TECNIS® TORIC II Intraocular Lens (IOL)
- Where
- 12 sites in United States
- Volunteers
- 54 people
- Sponsor
- Johnson & Johnson Surgical Vision, Inc.
Overactive Bladder
An Implantable Microstimulator for the Chronic Treatment of Urinary Urgency-Frequency Syndrome
The goal of this study is to investigate the safety and effectiveness of a new implanted device designed to treat Urinary Urgency-Frequency Syndrome.
- Trial name
- NCT00131573
- Testing
- bion
- Where
- 11 sites in United States
- Volunteers
- 118 people
- Sponsor
- Boston Scientific Corporation