Clinical trials: Implants
Hearing Loss
Littlears Auditory Questionnaire: Validation Study in CI Children
The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory behavior in children during the first two (hearing) years.
- Trial name
- LittlEars (NCT00785707)
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Med-El Corporation
Electromagnetic Interference
Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices
Patients with implanted pacemaker (PM) or cardioverter-defibrillator (ICD) systems are restrained in daily life by possible electromagnetic interference (EMI).
- Trial name
- NCT01369706
- Testing
- Hand-held metal detector
- Where
- 2 sites in Germany, Greece
- Volunteers
- 388 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Healthy
Assessing the Safety and Efficacy of a Novel Subcutaneous Implant Insertion Device on Healthy Adults
The investigators have created a device designed to make it easier to insert pharmaceutical implants under the skin. The device uses a blood pressure cuff to hold the skin on a person's arm in place while a mechanical guide…
- Trial name
- NCT03621787
- Testing
- Implant insertion device
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Cardiomyopathy, Heart Failure
Evaluating Myocardial Injury for Defibrillation Threshold Testing Methods for ICD Implantation
The objective of this study is to evaluate myocardial injury, if any, as quantified by cardiac markers (Troponin-T) in defibrillation threshold (DFT) testing during implantation of implantable cardioverter defibrillators (ICDs)…
- Conditions
- Cardiomyopathy, Heart Failure, Cardiac Arrhythmia
- Trial name
- ULV (NCT02111993)
- Testing
- Standard Defibrillation Testing, Upper Limit of Vulnerability Testing
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of California, San Diego
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.
Heart Failure, Arrhythmias, Cardiac
Heart Failure and Sudden Cardiac Death Japan Registry
The purpose of this observational registry is to collect clinical events and outcome data in 4 different study populations (cohorts), with a majority of Japanese subjects, that are at risk of sudden cardiac death (SCD) and heart…
- Conditions
- Heart Failure, Arrhythmias, Cardiac, Sudden Cardiac Death
- Trial name
- HINODE (NCT03185832)
- Testing
- CRT-D, ICD, PM / CRT-P
- Where
- 34 sites in Japan
- Volunteers
- 354 people
- Sponsor
- Boston Scientific Corporation
Erythropoietic Protoporphyria
Phase III Confirmatory Study in Erythropoietic Protoporphyria
This is a randomized placebo-controlled study to be conducted in two parallel study arms for a six month period (three doses). Between 75 and 100 eligible patients will be enrolled.
- Trial name
- NCT01605136
- Testing
- Afamelanotide
- Where
- 7 sites in United States
- Volunteers
- 93 people
- Sponsor
- Clinuvel Pharmaceuticals Limited
Implant Capsular Contracture
Chemically Assisted Capsulectomy-A New Clinical Approach
The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.
- Trial name
- NCT00758667
- Testing
- Mesna
- Volunteers
- 20 people
- Sponsor
- Vanderbilt University
Geographic Atrophy, Macular Degeneration
A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration
This study will assess the safety and efficacy of the brimonidine intravitreal implant in participants with geographic atrophy due to age-related macular degeneration.
- Trial name
- BEACON (NCT02087085)
- Testing
- 400 µg Brimonidine Implant
- Where
- 41 sites in United States, Australia and 4 more
- Volunteers
- 310 people
- Sponsor
- Allergan
Vertebral Compression Fractures, Osteoporotic Vertebral Compression Fractures
Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant
The RECONSTRUCT study is a multi-center, prospective, single arm, post-market, pilot study to evaluate clinical and radiologic outcome data regarding the use of the Vertebral Implant PEEK (VIP) implant in the treatment of…
- Trial name
- RECONSTRUCT (NCT05337696)
- Testing
- Vertebral Implant PEEK Procedure, Vertebral Implant PEEK (VIP) implant
- Where
- 4 sites in United States
- Volunteers
- 23 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Parkinson's Disease, Essential Tremor
RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)
The purpose of this study is to assess the recharge feature of the Activa RC System in patients who are receiving Deep Brain Stimulation (DBS) for Parkinson's Disease (PD), Essential Tremor (ET), or dystonia.
- Conditions
- Parkinson's Disease, Essential Tremor, Dystonia
- Trial name
- RECHARGE (NCT00998660)
- Testing
- Activa RC
- Where
- 11 sites in United States, Austria and 4 more
- Volunteers
- 100 people
- Sponsor
- MedtronicNeuro
Postoperative Pain
Efficacy and Safety of a Collagen Bupivacaine Implant in Women Following Abdominal Hysterectomy
The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after abdominal…
- Trial name
- NCT00624910
- Testing
- Bupivacaine Collagen Sponge (CollaRx®)
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Innocoll
Hearing Loss, Sensorineural Hearing Loss
Non-significant Risk Study of a Cochlear Implant Headpiece
This study aims to evaluate a cochlear implant headpiece.
- Trial name
- NCT05488535
- Testing
- cochlear implant headpiece
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Advanced Bionics
TTR Cardiac Amyloidosis
Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors
Researchers are gathering information to see if using an FDA approved implantable device can help with monitoring of your heart arrhythmias.
- Trial name
- NCT04421040
- Testing
- Biotronik Biomonitor 3 implant of device, Biotronik Biomonitor 3 explant of device
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Mayo Clinic
Diabetes Mellitus, Diabetes Mellitus, Type 1
PROMISE Study: An Evaluation of an Implantable Continuous Glucose Sensor up to 180 Days
The purpose of this clinical investigation is to evaluate the accuracy of the Eversense® continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared with reference standard measurements up to 180…
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- PROMISE (NCT03808376)
- Testing
- Continuous Glucose Monitoring System
- Where
- 8 sites in United States
- Volunteers
- 208 people
- Sponsor
- Senseonics, Inc.
Tooth Extraction, Immediate Implant Placement
Ultrasound-based Imaging to Detect Early Changes of Hard and Soft Tissue Around Immediately Placed Implants With or Without Soft Tissue Augmentation
Mid-facial recession following immediate implant placement (IIP) in the place of a tooth poses a significant challenge for clinicians to treat.
- Trial name
- NCT05330702
- Testing
- Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft No Intervention: No Soft Tissue Augmentation, Tuberosity Connective Tissue Graft (CTG)
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of Iowa
Adult Cochlear Implant Recipients
CP1110 Sound Processor Feasibility
The clinical study aims to investigate the speech performance with the CP1110 Sound Processor, compared with the CP1000 Sound Processor, and inclusion of a noise reduction feature in the Automatic Scene Classifier..
- Trial name
- NCT04898673
- Testing
- CP1110, CP1000
- Where
- Australia
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Cochlear
Drug Interaction
Pharmacokinetics and Pharmacodynamics of the Etonogestrel Contraceptive Implant When Co-administered With Efavirenz
This study evaluates whether there is an interaction between etonogestrel, the progestin hormone released by the contraceptive implant Nexplanon, and efavirenz, a common medication used to treat HIV.
- Trial name
- NCT01980342
- Testing
- Efavirenz
- Where
- United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Partially Edentulous Jaw
Study on OsseoSpeed™ TX Implants in the Upper Jaw in a Chinese Population
The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior maxilla…
- Trial name
- NCT01389245
- Testing
- OsseoSpeed™ TX
- Where
- 3 sites in China
- Volunteers
- 42 people
- Sponsor
- Dentsply Sirona Implants and Consumables
Jaw, Edentulous, Partially, Acquired Absence of Single Tooth
Case Selection and Treatment Protocol for Immediate Dental Implants in the Esthetic Zone
In this study a tooth that needs to be extracted will be replaced by an implant (artificial root) placed at the same appointment as the extraction.
- Trial name
- NCT02154581
- Testing
- SLActive implant
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center at San Antonio