Clinical trials: Implants
Degenerative Sacroiliitis, Sacroiliac Joint Disruption
Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
The purpose of this study is to evaluate the use of the iFuse Implant System to treat degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint).
- Trial name
- SIFI (NCT01640353)
- Where
- 26 sites in United States
- Volunteers
- 194 people
- Sponsor
- SI-BONE, Inc.
Glaucoma and Ocular Hypertension
Safety and Efficacy of ENV515 Travoprost Extended Release (XR) in Patients With Bilateral Ocular Hypertension or Primary Open Angle Glaucoma
This is a multiple cohort study that will evaluate the safety and efficacy of ENV515 travoprost XR in patients with open-angle glaucoma or ocular hypertension.
- Trial name
- NCT02371746
- Testing
- ENV515-3 Travoprost XR, ENV515-1 Travoprost XR, ENV515-3-2 Travoprost XR
- Where
- 14 sites in United States
- Volunteers
- 41 people
- Sponsor
- Envisia Therapeutics
Cardiomyopathy, Dilated, Arrhythmia
Mental Stress Reduction in Defibrillator Patients
The purpose of this study is to assess the effectiveness of a 10 week program of Stress Management versus control Patient Education sessions on cardiac responses to mental stress in veterans with Implantable…
- Conditions
- Cardiomyopathy, Dilated, Arrhythmia, Anger, Stress
- Trial name
- NCT00624520
- Testing
- Cognitive Behavioral Stress Management (CBSM), Patient Education
- Where
- 2 sites in United States
- Volunteers
- 129 people
- Sponsor
- US Department of Veterans Affairs
Hearing Loss, Unilateral
Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss
This feasibility study evaluates whether children with unilateral, moderate to profound sensorineural hearing loss experience an improvement in speech perception, hearing in noise, localization, and quality of life with a…
- Trial name
- CIPUHL (NCT02963974)
- Testing
- Cochlear implant
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Bone Loss, Implant Complication
The Effects of Dis/Reconnection of Implant Abutments on Peri-implant Bone Levels
The aim of this study was to evaluate the effects of definitive abutment connection at the time of implant placement on peri-implant bone levels and soft tissue changes in posterior maxilla and mandible regions.
- Conditions
- Bone Loss, Implant Complication, Gingival Recession
- Trial name
- NCT04043286
- Testing
- Definitive abutment
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Loma Linda University
Non-inflammatory Degenerative Joint Disease
Journey™ UNI Post Market Clinical Follow-Up
This is a retrospective/prospective, open-label single cohort, multicenter study to collect relevant clinical data from subjects with unicompartmental degeneration of the knee in whom the Journey UNI UKS was previously implanted.
- Trial name
- Journey UNI (NCT03442231)
- Testing
- Journey UNI Unicompartmental Knee System
- Where
- 4 sites in United States, Canada
- Volunteers
- 131 people
- Sponsor
- Smith & Nephew, Inc.
Parkinson Disease
Clinical Evaluation of the Infinity Deep Brain Stimulation System
The purpose of this post-market study is to characterize the clinical performance of the Infinity Deep Brain Stimulation (DBS) system, including the Implantable Pulse Generator (IPG), directional DBS leads, extensions, iPad…
- Trial name
- PROGRESS (NCT02989610)
- Testing
- Omnidirectional stimulation, Directional stimulation
- Where
- 41 sites in United States, Australia and 6 more
- Volunteers
- 234 people
- Sponsor
- Abbott Medical Devices
Parkinson Disease
IPG Replacement Study (PREFERENCE-H)
This post-marketing evaluation has been designed to consistently investigate the subject's preference when switching from a Medtronic® constant voltage or constant current device to a St Jude Medical Infinity™ or St Jude Medical…
- Trial name
- PREFERENCE-H (NCT02963259)
- Testing
- SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system
- Where
- 14 sites in United States, Germany and 1 more
- Volunteers
- 17 people
- Sponsor
- Abbott Medical Devices
Retinitis Pigmentosa
A Study of Encapsulated Cell Technology (ECT) Implant for Participants With Early Stage Retinitis Pigmentosa
The purpose of this study is to look at the safety and effectiveness of CNTF implants on vision in persons with retinitis pigmentosa, Usher type II \& III, and Choroideremia.
- Trial name
- NCT00447980
- Testing
- NT-501
- Where
- 12 sites in United States
- Volunteers
- 73 people
- Sponsor
- Neurotech Pharmaceuticals
Severe to Profound Hearing Loss, in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System
Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.
- Trial name
- NCT01616576
- Testing
- Control first, then Experimental, Experimental first, then Control
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Advanced Bionics
Breast Reconstruction, Breast Augmentation
Mentor MemoryGel Post-Approval Study
In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional…
- Conditions
- Breast Reconstruction, Breast Augmentation, Breast Revision
- Trial name
- MGPAS (NCT00756652)
- Testing
- Mentor Silicone Gel-Filled Breast Implants, Saline Breast Implants
- Volunteers
- 42,491 people, healthy volunteers welcome
- Sponsor
- Mentor Worldwide, LLC
Bone Substitutes, Bone Defect
Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study)
Multi-center, international, prospective, open-label, single-arm, first-in-human clinical investigation. The Patients enrolled in this clinical investigation will undergo a scheduled surgery for the treatment of long bone defects…
- Trial name
- NCT03884790
- Testing
- surgical repair of long bone defects
- Where
- 8 sites in Bosnia and Herzegovina, Israel and 4 more
- Volunteers
- 16 people
- Sponsor
- GreenBone Ortho S.p.A.
Arthritis
A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing
This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral…
- Trial name
- CHRA (NCT02405208)
- Testing
- PyroTITAN HRA
- Where
- 5 sites in Australia, France and 2 more
- Volunteers
- 156 people
- Sponsor
- Smith & Nephew, Inc.
Arrhythmogenic Right Ventricular Cardiomyopathy
Pilot Randomized Trial With Flecainide in ARVC Patients
Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited arrhythmia disorder with high risk of ventricular tachycardia or fibrillation, and implantable cardioverter defibrillator remains as therapy of choice.
- Trial name
- NCT03685149
- Testing
- Flecainide Pill
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- University of Rochester
Primary Open Angle Glaucoma
Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)
This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity.
- Trial name
- NCT01539239
- Testing
- Hydrus Aqueous Implant, Cataract surgery
- Where
- 38 sites in United States, Canada and 7 more
- Volunteers
- 1,143 people
- Sponsor
- Ivantis, Inc.
Acute Myocardial Infarction
CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction
The purpose of this study is to assess the incidence of tachy- and bradyarrhythmic episodes in patients with acute myocardial infarction with depressed ventricular function and to determine the predictive value of several…
- Trial name
- NCT00145119
- Where
- Netherlands
- Volunteers
- 312 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Implantable Electronic Device Infection
TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD
The purpose of this study is to compare the incidence of cardiac implantable electronic device (CIED) infection and CIED mechanical complication after CIED replacement with a high-power cardiac implantable electronic device…
- Trial name
- Centurion (NCT01043705)
- Where
- 52 sites in United States
- Volunteers
- 1,262 people
- Sponsor
- TYRX, Inc.
Obesity
Study of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner
The purpose of this study is to determine whether the GI Endobarrier Liner can be reimplanted.
- Trial name
- NCT01372501
- Testing
- Endobarrier Liner
- Where
- Chile
- Volunteers
- 19 people
- Sponsor
- Morphic Medical Inc.
Prostate Cancer
Ultrasound-Guided Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer Previously Treated With External-Beam Radiation Therapy
RATIONALE: Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. PURPOSE: This phase II trial is studying the side effects and how well ultrasound-guided implant radiation…
- Trial name
- NCT00450411
- Testing
- 125-Iodine, 103-palladium
- Where
- 17 sites in United States, Canada
- Volunteers
- 100 people
- Sponsor
- Radiation Therapy Oncology Group
Osteoarthritis, Hip
Mini Stem Radiostereometric Analysis Study
The objectives of this study are to assess migration of the MIS Stem compared to the Synergy Hip System using Radiostereometric Analysis (RSA), and to assess the long-term safety and effectiveness of the study device.
- Trial name
- MISRSA (NCT01064531)
- Testing
- MIS Femoral Neck Stem implant
- Where
- Canada
- Volunteers
- 41 people
- Sponsor
- Smith & Nephew, Inc.