Clinical trials: Implants, open to volunteers
Device:MRI
Magnetic Resonance Imaging (MRI) in Patients With Pacemakers and Implanted Cardioverter Defibrillators
Ferromagnetic Implants such as permanent pacemakers (PPM's) and Implantable Cardioverter Defibrillators (ICD's) have traditionally been accepted as contraindications to Magnetic Resonance Imaging (MRI) due to safety concerns.
- Trial name
- NCT02888353
- Testing
- Device: MRI
- Where
- United States
- Volunteers
- 4,500 people
- Sponsor
- Johns Hopkins University
Heart Diseases
ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices
The registry is an international, multicenter, non-randomized, non-invasive study to assess the safety, performance and usability of the Occlutech Accessories "Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP)…
- Trial name
- NCT05174442
- Where
- 36 sites in Germany, Turkey (Türkiye)
- Volunteers
- 685 people
- Sponsor
- Occlutech International AB
Profound Hearing Loss, Cochlear Implants
The Value Electrical Stapedial Reflex Thresholds (eSRTs) Cochlear Implant Mapping
One of the most significant challenges in cochlear implant programming, particularly for very young children and those with an associated pathologies, is the measurement of subjective comfort levels (= C-Subjective).
- Trial name
- eSRT (NCT06051006)
- Testing
- ESR and ECAP measurements, Device setting, Speech audiometry
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Deafness
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
This is a basic investigational research study conducted with hearing impaired adults and children who use cochlear implant or auditory brainstem implant (ABI) devices.
- Trial name
- NCT05810220
- Testing
- Electrode-Neural Interface
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- NYU Langone Health
Complication, Prosthesis Durability
SEBBIN Silicone Gel-filled Testicular Implants
This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device.
- Trial name
- NCT04968470
- Where
- 2 sites in Belgium, France
- Volunteers
- 100 people
- Sponsor
- Groupe SEBBIN
Breast Implant Revision
LTFU of PCL Breast Scaffolds Used in 2021-BRV-004
The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with…
- Trial name
- NCT07383012
- Where
- Australia
- Volunteers
- 19 people
- Sponsor
- BellaSeno Pty Ltd
Obstructive Sleep Apnea of Adult
An Extension Study to Assess the Long-term Safety of the Genio® System
The objective of this study is to assess the long-term safety of the Genio® system in adult OSA patients with and without complete concentric collapse of the soft palate who have successfully been implanted with the Genio IS in a…
- Trial name
- OLE (NCT05939141)
- Testing
- Genio System
- Where
- 7 sites in Australia
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Nyxoah S.A.
Peri-Implant Health
Plaque and Bleeding on Probing Around Implants Supporting Fixed Full-Arch Dental Prostheses
This observational study examines plaque, hard deposits (calculus), and gum bleeding around dental implants supporting fixed full-arch dental prostheses.
- Trial name
- NCT07898956
- Testing
- Prosthetic Maintenance History
- Where
- Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Nicola Alberto Valente, DDS, MS, PhD
Bone Loss, Bone Defects
Evaluation of the Safety, Feasibility, and Early Clinical Outcomes of Patient-Specific Bone Defect Implants Fabricated From Titanium Alloy (Ti-6Al-4V) Using 3D Printing Technology
The goal of this clinical trial is to evaluate the safety and feasibility of patient-specific bone defect implants fabricated from Ti-6Al-4V using 3D printing technology and to assess early clinical outcomes within the first 12…
- Trial name
- NCT07540156
- Testing
- Patient-specific 3D-printed Ti-6Al-4V bone implant
- Where
- Vietnam
- Volunteers
- 10 people
- Sponsor
- VinUniversity
Survival of the Ponto Wide Implant
10-year Follow-up of the Ponto Wide-implant
The goal of this single center, prospective study is to investigate the survival of the Ponto Wide Implant at least 10 years after implantation. Secondary objectives are: 1.
- Trial name
- NCT06772714
- Where
- Netherlands
- Volunteers
- 64 people
- Sponsor
- University Medical Center Nijmegen
Arrhythmia
Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry
The primary objectives for the registry is to evaluate the overall incidence of serious complications or adverse events for primary implants and replacement devices, and assess the cost and time efficiency for both physicians and…
- Trial name
- ASC ICD Reg (NCT03604133)
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- QuesGen Systems Inc
Amputation of Upper Limb
A Multicenter, Multinational, Cohort Long-term Post-market Clinical Follow-up (PMCF) of the Safety and Efficacy of the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System When Used for Transhumeral Implantation in Amputee Patients
This non-interventional clinical investigation is initiated for the purpose of long-term Post-Market Clinical Follow-up (PMCF) and the follow-up time of patients is expected to span from 6 months to >20 years in function.
- Trial name
- ReTHro (NCT06753110)
- Testing
- OPRA transhumeral
- Where
- 6 sites in Australia, Austria and 3 more
- Volunteers
- 70 people
- Sponsor
- Integrum
Tooth Loss, Dental Implant
A 36-month Analysis of the Clinical Performance of Individualized CAD/CAM-produced Dental Implants: a Cohort Study
The goal of this prospective cohort study is to evaluate the clinical performance of a new generation of customized CAD/CAM pre-fabricated root-analog dental implants over a 36-month period.
- Trial name
- NCT06576284
- Where
- Brazil
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Patients With an Implanted S-ICD Who Continue to Exercise Regularly
Safety of Sports for Patients With a Subcutaneous Implantable Cardioverter Defibrillator
A multicenter observational study designed specifically to collect data on the safety of sport activities in patients with implanted S-ICD systems.
- Trial name
- SPORT-SICD (NCT05754138)
- Testing
- Sport SICD
- Where
- Israel
- Volunteers
- 500 people
- Sponsor
- Eli Sprecher, MD
Post-Op Complication
A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery
The purpose and objectives of this study is to investigate whether reducing the existing arm restrictions on patients who receive Cardiac Implantable Electronic Devices (CIED) will result in an improved patient experience post…
- Trial name
- LENIENT (NCT04915261)
- Testing
- Lenient Arm Restriction, Strict Arm Restriction
- Where
- Canada
- Volunteers
- 6,300 people, healthy volunteers welcome
- Sponsor
- Ottawa Heart Institute Research Corporation
Deafness
Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS
The principal aim of this study is to evaluate the cortical developement of perceptual skills and executive functions over time, in children with cochlear implants aged 10-24 months and 3-7 years compared with normally hearing…
- Trial name
- HearCog (NCT04495660)
- Testing
- Near InfraRed Spectroscopy (fNIRS), Passive perceptual stimulation, Task A not B
- Where
- France
- Volunteers
- 80 people
- Sponsor
- University Hospital, Toulouse
Mitral Valve Prolapse, Ventricular Arrhythmias and Cardiac Arrest
Mitral Valve Prolapse Arrhythmic Risk
Mitral valve prolapse (MVP) is common with a 2-3 % prevalence in the general association and generally associated with a favorable prognosis.
- Trial name
- MVP-Risk (NCT07830888)
- Testing
- Risk prediction model
- Where
- Norway
- Volunteers
- 500 people
- Sponsor
- Oslo University Hospital
Peri-Implant Health, Peri-Implantitis and Peri-implant Mucositis
Monitoring of Implant Diseases: Diagnosis and Monitoring With aMMP-8 Test Technology
68 patients underwent the aMMP-8 chair-side test as well as clinical traditional measurement methods. Those who had one or more implants in their mouth were selected as patients.
- Trial name
- IMP_TRE (NCT06761521)
- Testing
- Peri-Implantitis and Peri-implant mucositis
- Where
- Finland
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Hanna Lahteenmaki
Cochlear Implant Listeners
Pediatric Cochlear Implant Remote Programming and Assessment
This is a prospective, interventional study to evaluate efficacy and end user satisfaction of remote cochlear implant programming in the pediatric population.
- Trial name
- NCT07035873
- Testing
- Remote Programming, Remote Speech Perception
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Nationwide Children's Hospital
Reconstruction of Massive Bone Loss (Oncologic and Non-oncologic)
Prospective Evaluation of Adler Laboratory's Massive Prosthetic Implants in Oncological and Non-oncological Situations
Massive prostheses are the standard treatment for extensive bone loss, whether caused by cancer or other factors (complex fractures, multiple revisions, infections).
- Trial name
- IMPULSION (NCT07369778)
- Where
- France
- Volunteers
- 375 people
- Sponsor
- Nantes University Hospital