Clinical trials: Implants
Hearing Loss
Sound Processing Innovations in Adult and Paediatric Cochlear Implant Recipients.
This is a feasibility, prospective with sequential enrolment, multicenter, clinical investigation in adults and paediatrics with a CE approved Nucleus cochlear implant. Subjects older than 5 years will be included.
- Trial name
- NCT05476328
- Testing
- SPACE, OPAL-SPACE, ACE
- Where
- 5 sites in Australia, Belgium
- Volunteers
- 8 people
- Sponsor
- Cochlear
Ankle Arthroplasty, Prosthesis User
3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Arthroplasty
Patients who have had a total ankle joint replacement surgery typically have limited movement in their ankles possibly due to the fact that commonly used ankle joint prosthetic devices only allow limited axes of motion.
- Conditions
- Ankle Arthroplasty, Prosthesis User, Joint Disease
- Trial name
- NCT03575975
- Testing
- Total Ankle Replacement Prosthesis
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Georgia Institute of Technology
Vitiligo
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)
The purpose of this study was to evaluate the efficacy and safety of afamelanotide, when combined with narrowband ultraviolet B (NB-UVB) phototherapy, in patients with nonsegmental vitiligo.
- Trial name
- NCT04525157
- Testing
- Afamelanotide
- Volunteers
- 21 people
- Sponsor
- Clinuvel Pharmaceuticals Limited
High Frequency Sensorineural Hearing Loss
Hybrid L24 New Enrollment Post Approval Study
This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.
- Trial name
- HNE (NCT02379819)
- Testing
- Nucleus Hybrid L24 Implant
- Where
- 19 sites in United States
- Volunteers
- 52 people
- Sponsor
- Cochlear
Opioid-use Disorder
Pharmacokinetic Study of Vivitrol in Healthy Participants
This is a Phase I, single-center, single arm, open-label study, to establish the pharmacokinetic (PK) parameters of Vivitrol 380 mg IM injection (IP), a US Food and Drug Administration (FDA) approved medication.
- Trial name
- NCT04716881
- Testing
- Naltrexone 380 MG
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Go Medical Industries Pty Ltd
Hernioplasty
Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant
Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy hernioplasty and assess the relative bioavailability of Xaracoll compared to a local bupivacaine infiltration.
- Trial name
- NCT02232178
- Testing
- 2 100mg Xaracoll implants, 3 100mg Xaracoll implants, 150mg Bupivacaine HCl injection
- Where
- 5 sites in United States
- Volunteers
- 64 people
- Sponsor
- Innocoll
First Degree AV Block
Restoration of Atrioventricular Synchrony Trial
The objective of the trial is to observe the effects of restoring atrioventricular (AV) synchrony in subjects with prolonged PR intervals.
- Trial name
- RESTORE-AV (NCT01275833)
- Testing
- Cardiac resynchronization therapy-defibrillator
- Volunteers
- 2 people
- Sponsor
- Boston Scientific Corporation
Arthritis, Osteoarthritis, Knee
Switching Drug Therapy for the Prevention of Blood Clot Formation From Enoxaparin to Rivaroxaban After Orthopedic Surgery for Either Total Hip or Total Knee Replacement
The study will describe the short-term effects the study drug, rivaroxaban, has on the body when a patient is switched from enoxaparin injection (by needle) to oral rivaroxaban (by mouth) for the prevention of blood clotting in…
- Conditions
- Arthritis, Osteoarthritis, Knee, Osteoarthritis, Hip, Thromboembolism
- Trial name
- NCT01094886
- Testing
- Rivaroxaban
- Where
- 5 sites in United States
- Volunteers
- 56 people
- Sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
Tooth Loss
Performance Evaluation of FullCeram Implants in Single Tooth Gaps
Straumann Monotype FullCeram implants serve as a suitable alternative for implant therapy especially in the aesthetic zone The survival rate of Straumann Ceramic implants should be at least 85% (max 6 implant losses out of 40…
- Trial name
- NCT02163395
- Testing
- FullCeram implant
- Where
- 3 sites in Germany
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Institut Straumann AG
Hearing Loss
Multi-center Study to Examine Changes to the Environment Surrounding the Electrodes in the Cochlea and to Capture the Most Challenging Listening Environments Experienced by Persons With a Cochlear Implant
This early feasibility study aims to collect pilot data on impedance measurements in real-world environments and to collect real-world and difficult listening situations and the factors impacting this, reflecting situations the…
- Trial name
- DICE (NCT06173687)
- Testing
- The impedance measurement task using the Mobile Research App (MRA)
- Where
- 4 sites in Australia, Belgium and 1 more
- Volunteers
- 51 people
- Sponsor
- Cochlear
Heart Failure, Congestive
PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure
The purpose of this study is to determine the value of diagnostic data obtained from Medtronic implantable cardioverter defibrillators (ICDs) with cardiac resynchronization therapy (CRT) to evaluate cardiovascular and heart…
- Trial name
- NCT00279955
- Testing
- Cardiac Resynchronization Therapy Device
- Where
- 93 sites in United States
- Volunteers
- 1,024 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Schizophrenia
Safety and Tolerability of Risperidone Implants
A one year, open-label, study to evaluate the safety and tolerability of risperidone implants as a maintenance treatment in patients with schizophrenia
- Trial name
- NCT02773576
- Testing
- Risperidone implant
- Where
- United States
- Volunteers
- 140 people
- Sponsor
- Braeburn Pharmaceuticals
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
Conductive Hearing Loss, Conductive and Sensori-neural Hearing Loss in the Same Ear
Wide Diameter Bone Anchored Implant Study
To assess implant stability, implant loss, adverse skin reactions, and Quality of Life Benefit following implantation of the Ponto 4.5mm Wide Diameter implant.
- Conditions
- Conductive Hearing Loss, Conductive and Sensori-neural Hearing Loss in the Same Ear, Unilateral, Profound Sensori-neural Hearing Loss
- Trial name
- NCT01671176
- Testing
- Wide diameter bone anchored implant
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Oticon Medical
Parkinson's Disease
CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation
The objective of the study is to compare different deep brain stimulation (DBS) settings using the commercially approved Boston Scientific Neuromodulation Vercise system.
- Trial name
- CUSTOM-DBS (NCT01896115)
- Testing
- Vercise DBS settings
- Where
- 10 sites in United States, Austria and 3 more
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
Jaw, Edentulous, Partially
Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior Mandible and Maxilla
The purpose of this study is To demonstrate that there is no difference in change in bone level around P.004 implants between 1st stage surgery and 6 months post surgery when transmucosal implant placement is compared to…
- Trial name
- NCT00906425
- Testing
- Straumann Bone Level Implant
- Where
- 11 sites in United States, Australia and 5 more
- Volunteers
- 145 people
- Sponsor
- Institut Straumann AG
Tooth Loss, Ceramic Implant
PMCF Study of CeraRoot Ceramic Implants One-piece: 3 Years Follow up
The main objective is to evaluate the success / failure rate of CeraRoot ceramic implants (one piece) during three year follow up.
- Trial name
- NCT04598776
- Where
- Spain
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- CeraRoot SL
Jaw, Edentulous, Partially
Straumann Roxolid Multi-Center Study
The primary objective of this study is to demonstrate non-inferiority of the Straumann Bone Level Ø 3.3 mm NC SLActive Roxolid Implants compared to Straumann Bone Level Ø 4.1 mm RC SLActive Roxolid Implants based on mean crestal…
- Trial name
- NCT01842958
- Testing
- Straumann Bone Level Implants, 4.1 mm implant diameter, Straumann Bone Level Implants, 3.3 mm implant diameter
- Where
- 5 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Institut Straumann AG
Hernioplasty
Pharmacokinetics, Relative Bioavailability and Safety of INL-001 Compared to Marcaine After Open Hernioplasty
This is a multicenter randomized, single-blind, controlled study. The primary objectives of this study are to obtain the pharmacokinetic profile and the relative bioavailability of the INL-001 matrix during and after open…
- Trial name
- NCT03234374
- Testing
- INL-001 (bupivacaine HCl collagen implant), Marcaine 0.25% infiltration
- Where
- 5 sites in United States
- Volunteers
- 52 people
- Sponsor
- Innocoll
Knee Arthroplasty, Total
iTotal Pilot Study of ConforMIS Custom Total Knee Implant
To compare the outcomes of patients receiving the ConforMIS custom total knee implant to the outcomes of patients who receiving an off-the-shelf total knee implant.
- Trial name
- NCT02186587
- Testing
- ConforMIS custom total knee
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Missouri-Columbia