Clinical trials: Implants
Congestive Heart Failure
Effect of Posture on Left Ventricular (LV) Transvenous Lead Capture Thresholds (EXPECT)
The purpose of this study is to determine whether changes in a patient's position affect LV capture thresholds in a clinically significant way.
- Trial name
- EXPECT (NCT01520714)
- Testing
- Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Baylor Research Institute
Distal Radius Fractures
Proof-of-concept Study With NVDX3 for Treatment of Distal Radius Fractures.
Prospective, single arm, monocentric clinical study to test NVDX3 in patients suffering from distal radius fracture. NVDX3 will be implanted during a single surgical intervention.
- Trial name
- NCT05987033
- Testing
- NVDX3
- Where
- Luxembourg
- Volunteers
- 11 people
- Sponsor
- Novadip Biosciences
Knee Prosthesis
In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty
This study will compare the kinematics data collected from patients with implants created by different manufacturers to see which of these implants provides a more normal-like kinematic pattern compared to the normal knee.
- Trial name
- NCT01864434
- Testing
- Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA), Zimmer PCR TKA
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- The University of Tennessee, Knoxville
Management of Chronic Pain
Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration
The purpose of this study is to determine the safety and efficacy of hydromorphone hydrochloride by intrathecal administration using a programmable implantable pump.
- Trial name
- NCT01709721
- Testing
- Hydromorphone Hydrochloride, Programmable Implantable pump
- Where
- United States
- Volunteers
- 153 people
- Sponsor
- Piramal Critical Care, Ltd.
Fractures, Closed
Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)
People who have been scheduled for surgery using Bone Morphogenic Protein (called BMP-2) and an incisional vacuum assisted closure device (called IVAC) will be asked to join this study.
- Trial name
- NCT00829621
- Testing
- 75 mmHg suction, 125 mmHg
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Missouri-Columbia
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
Phantom Limb
Epidural Spinal Cord Stimulation for Sensory Restoration and Phantom Limb Pain in Upper-Limb Amputees
Individuals with upper-limb amputation usually have intact nerves within the residual limb, and studies have demonstrated that electrical stimulation of those nerves can produce sensations that appear to emanate from the…
- Trial name
- PhantomLimb (NCT02684201)
- Testing
- Boston Scientific Stimulator Lead
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Lee Fisher, PhD
Dental Implant
A Randomized Prospective Clinical Trial Comparing Single Tooth Implant 3 Loading Protocols
This is a research study to test the clinical procedure and not the FDA approved medical device. This project will screen up to 80 volunteers to enroll 40 active subjects to receive a single tooth implant on an anterior…
- Trial name
- NCT00607022
- Testing
- dental implant
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Clark Stanford
Hearing Loss
Evaluation of the Benefits for Overall Health Following Cochlear Implant Treatment in the Elderly Population
The purpose of this study is to show that cochlear implant treatment improves the overall health related quality of life and general well-being in elderly individuals.
- Trial name
- NCT03072862
- Testing
- Commercial Nucleus Cochlear Implant Systems
- Where
- 8 sites in France, Israel and 2 more
- Volunteers
- 100 people
- Sponsor
- Cochlear
Heart Failure, Ventricular Arrythmias
Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds
This study is a prospective, non-randomized, multi-center clinical trial that will assess the safety and effectiveness of investigational models of the Promote™ RF CRT-D and Current™ RF ICD devices.
- Trial name
- NCT00746356
- Testing
- Testing of the autocapture features of the device
- Where
- 5 sites in United States
- Volunteers
- 128 people
- Sponsor
- Abbott Medical Devices
Cataract
Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis or Acri.LISA
This is a study to compare visual outcomes of subjects bilaterally implanted w/ReSTOR to subjects bilaterally implanted with the Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL
- Trial name
- NCT00721253
- Testing
- ReSTOR, Tecnis, Acri.LISA
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Alcon Research
Non-left Bundle Branch Block, Ischemic or Non-ischemic Cardiomyopathy
CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients
The purpose of this study is to analyze the effect of left ventricular lead pacing location in the non-left bundle branch block (non-LBBB) heart failure patient population.
- Trial name
- ENHANCE CRT (NCT01983293)
- Testing
- QLV based implant strategy, Standard of care implant strategy
- Where
- 32 sites in United States
- Volunteers
- 248 people
- Sponsor
- Abbott Medical Devices
High Frequency Sensorineural Hearing Impairment, Hearing Disorders in Children
Outcomes in Children With Pre-operative Residual Hearing
Purpose: Routine clinical care and pilot study data has shown evidence of postoperative hearing preservation in pediatric cochlear implant (CI) recipients.
- Trial name
- NCT03379870
- Testing
- Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting, Electric Acoustic Speech Processor: Full-electric stimulation fitting
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Alveolar Ridge Abnormality
A Study of Dental Implants Coated With Bone Morphogenetic Protein
The purpose of the study is to evaluate implant stability and stimulate clinically relevant horizontal and vertical new bone formation around Nobel Biocare's Bone Inductive Implant.
- Trial name
- NCT00422279
- Testing
- Nobel Replace Tapered Groovy
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Nobel Biocare
Sensorineural Hearing Loss, Bilateral
CI532 - Early Experience Study
To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.
- Trial name
- NCT02755935
- Testing
- Cochlear Nucleus CI532
- Where
- 6 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Cochlear
Deafness, Hearing Loss
Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)
The rationale behind this post-market clinical follow-up investigation is to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that are candidates for…
- Conditions
- Deafness, Hearing Loss, Hearing Loss, Conductive
- Trial name
- NCT02022085
- Testing
- Baha Attract System
- Where
- 6 sites in United States, Netherlands and 2 more
- Volunteers
- 54 people
- Sponsor
- Cochlear Bone Anchored Solutions
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
Abdominal Wall Defects
A Retrospective Study Evaluating the Use of Permacol Surgical Implant in the Repair of Abdominal Wall Defects
To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in the treatment of abdominal wall defects.
- Trial name
- NCT01214252
- Testing
- Permacol Surgical Implant
- Where
- United States
- Volunteers
- 343 people
- Sponsor
- Medtronic - MITG
Heart Failure
C-Pulse® System European Multicenter Study
The study is designed to observe the clinical outcomes of heart failure patients treated with C-Pulse® System in the usual manner and according to the approved indications and contraindications.
- Trial name
- OPTIONS-HF (NCT01872949)
- Where
- 8 sites in Austria, Germany
- Volunteers
- 15 people
- Sponsor
- Nuwellis, Inc.
Cataract
Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.
To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy…
- Trial name
- DEXTENZA (NCT05372315)
- Testing
- Dextenza 0.4Mg Ophthalmic Insert
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Iworks Laser and Vision Center