Clinical trials: Implants
Cardiac Pacemaker, Artificial, Implantable Cardioverter-Defibrillator
Actions Elicited by In-hospital Follow-up of Cardiac Devices
This study will enroll all patients who will attend an in-hospital follow-up of cardiac device since February 22nd 2010 to June 21st 2010.
- Trial name
- ATHENS (NCT01073449)
- Testing
- In-hospital follow-up of cardiac device
- Where
- 8 sites in Italy
- Volunteers
- 3,362 people
- Sponsor
- Cliniche Humanitas Gavazzeni
Ventricular Tachyarrhythmias
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system.
- Trial name
- Chronic II (NCT00853645)
- Testing
- Subcutaneous Implantable Defibrillator (S-ICD) System
- Where
- 2 sites in New Zealand
- Volunteers
- 6 people
- Sponsor
- Boston Scientific Corporation
Knee Osteoarthritis
A Prospective Study to Evaluate the iTotal Knee and iPoly XE Tibial Inserts
This study is designed to evaluate the clinical outcomes of subjects who have recently undergone surgery with the iTotal® Cruciate Retaining (CR) Total Knee Replacement System (KRS) who have also had iPoly XE Tibial Inserts…
- Trial name
- NCT03289754
- Testing
- iPoly XE tibial insert with ConforMIS iTotal KRS
- Where
- Germany
- Volunteers
- 52 people
- Sponsor
- Restor3D
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative…
- Trial name
- NCT03752866
- Testing
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Where
- 28 sites in Australia, Belgium and 7 more
- Volunteers
- 1,001 people
- Sponsor
- Abbott Medical Devices
Breast Augmentation
European New Texture Implant Clinical Experience With Round Breast Implants
The purpose of this study is to obtain clinical experience with the use of new texture, round breast implants in bilateral primary breast augmentation.
- Trial name
- NCT01639742
- Testing
- New texture round breast implants
- Where
- 4 sites in Germany, Sweden and 1 more
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Allergan
Cataract
Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOL
The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to placebo in patients…
- Trial name
- NCT01602068
- Testing
- Dexamethasone Phosphate Ophthalmic, 100 mM Sodium Citrate Buffer
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Eyegate Pharmaceuticals, Inc.
Overactive Bladder
Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)
Study objectives: To report feasibility data for safety and effectiveness of the study device. Study device: Nine Continents Medical implantable tibial nerve stimulator (ITNS) model 9C-680 with programmer model 9C-580.
- Trial name
- NCT04115228
- Testing
- Implantation and neuromodulation therapy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Nine Continents Medical, Inc.
Hearing Loss, Sensorineural
Expanded Indications in the Adult Cochlear Implant Population
The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit…
- Trial name
- NCT03236909
- Testing
- MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System
- Where
- 5 sites in United States, Canada
- Volunteers
- 44 people
- Sponsor
- Med-El Corporation
Immediate Dental Implant Loading
Immediate Loading Versus Delayed Loading in Single-implant
The purpose of this prospective randomized clinical study was to compare implant survival, patient satisfaction, and radiographic, clinical, and aesthetic outcomes following immediate loading (IL) and delayed loading (DL) of…
- Trial name
- NCT02770846
- Testing
- Immediate loading, Delayed loading
- Where
- Sweden
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Folktandvården Skåne AB
Knee Injuries
Optimized Loading Response by JOURNEY II BCS Knee Increases Daily Physical Activity and Functions
Smith \& Nephew's first edition of the Journey posterior stabilizing total knee arthroplasty was analyzed by the Center for Musculoskeletal Research in a past research study, and it was determined that subjects experienced more…
- Trial name
- NCT02335710
- Testing
- Journey II BCS TKA
- Where
- 3 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- The University of Tennessee, Knoxville
Implantable Defibrillator User
Plexa ICD Lead Registry
The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead.
- Trial name
- NCT03103503
- Where
- 28 sites in United States
- Volunteers
- 901 people
- Sponsor
- Biotronik, Inc.
Failure of Osseointegration of Dental Implant
Survival and Success of MIS C1 Implants- a Field Study
The aim of the present study is to evaluate the 1-year and 3-year survival and success of MIS® C1 implants with a length of 10-15mm. Specific Aims 1. To study 1-year and 3-year implant survival rate C1 implants 2.
- Trial name
- NCT01707108
- Testing
- Dental Implant (MIS Technologies)
- Where
- Israel
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Rambam Health Care Campus
Breast Augmentation
European New Texture Implant Clinical Experience With Shaped Breast Implants
The purpose of this study is to obtain clinical experience with the use of new texture, shaped breast implants in bilateral primary breast augmentation.
- Trial name
- NCT01639755
- Testing
- new texture shaped breast implants
- Where
- 2 sites in Sweden
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Allergan
Telemedicine
Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants
The purpose of this study is to demonstrate the safety and efficacy of Nucleus cochlear implant programming via telecommunication.
- Trial name
- TEL (NCT02644343)
- Testing
- Custom Sound
- Where
- 4 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Cochlear
Macular Edema
A Retrospective Data Collection Study in Patients Receiving Dexamethasone Intravitreal Implant (Ozurdex®) for Macular Oedema Due to Retinal Vein Occlusion (RVO)
This study will use retrospective data to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular oedema due to Retinal Vein Occlusion (RVO).
- Trial name
- NCT01445626
- Testing
- dexamethasone intravitreal implant 0.7 mg
- Where
- Germany
- Volunteers
- 87 people
- Sponsor
- Allergan
Diabetic Macular Edema
Dexamethasone Intravitreal Implant for the Treatment of Persistent Diabetic Macular Edema
Laser photocoagulation and intravitreal anti-vascular growth factor injections are commonly used treatment options for individuals with diabetic macular edema.
- Trial name
- DIME (NCT02471651)
- Testing
- Dexamethasone intravitreal implant (0.7 mg), Intravitreal anti-VEGF injection
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- California Retina Consultants
Glaucoma
Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms
Assess the safety and performance of the Miami InnFocus Drainage Implant in patients suffering from glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg…
- Trial name
- NCT00772330
- Testing
- Glaucoma Drainage Device
- Where
- Dominican Republic
- Volunteers
- 23 people
- Sponsor
- InnFocus Inc.
Atrial Fibrillation
Comparison of the Performance of ICM and CIED in Detecting AF
The aim of this project is to study the performance of the two most commonly used Implantable Cardiac Monitors in detecting AF episodes and explore how the new connectivity can empower patients and improve patient care.
- Trial name
- ID-AF (NCT04940156)
- Testing
- Confirm Rx (Implantable Cardiac Monitor), Reveal LINQ (Implantable Cardiac Monitor)
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Oxford University Hospitals NHS Trust
Heart Failure
Efficacy and Safety of ICD Remote Monitored Exercise Testing to Improve Heart Failure Outcomes: REMOTE HF-ACTION
This single center randomized controlled trial will involve 50 medically stable outpatients with HF, reduced ejection fraction, and previously implanted ICD or CRT-D devices followed longitudinally on the Abbott Medical Merlin…
- Trial name
- x (NCT04629066)
- Testing
- Remote Cardiac Rehabilitation (CR)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Duke University
Glaucoma Open-angle
Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution
This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution.
- Trial name
- NCT02754596
- Testing
- Travoprost Intraocular Implant, high elution, Travoprost Intraocular Implant, low elution, Timolol Maleate Ophthalmic Solution, 0.5%
- Where
- United States
- Volunteers
- 154 people
- Sponsor
- Glaukos Corporation