Clinical trials: Implants
Atrial Fibrillation, Syncope
BIO|CONCEPT.BIOMONITOR III
The objective of the study is to confirm the safety and efficacy of the BIOMONITOR III system. Furthermore, the insertion procedure, the use and handling of the incision and insertion tools and the sensing quality of the…
- Conditions
- Atrial Fibrillation, Syncope, Tachyarrhythmia
- Trial name
- NCT03850327
- Testing
- BIOMONITOR III
- Where
- 7 sites in Australia
- Volunteers
- 48 people
- Sponsor
- Biotronik SE & Co. KG
Obesity & Overweight
Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant
The study will evaluate the safety, tolerability and drug levels of a semaglutide implant placed just under the skin for a period of 4 weeks compared to 4 weekly injections of semaglutide (Wegovy) in overweight/obese participants…
- Trial name
- SLIM-1 (NCT07430059)
- Testing
- Semaglutide Implant (NPM-139), Semaglutide (Wegovy) weekly injection
- Volunteers
- 20 people
- Sponsor
- Vivani Medical, Inc
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 147 subjects with unicompartmental degeneration of the knee in whom the Journey UNI UKS was previously…
- Trial name
- Journey UNI (NCT03442231)
- Testing
- Journey UNI Unicompartmental Knee System
- Where
- 4 sites in United States, Canada
- Volunteers
- 147 people
- Sponsor
- Smith & Nephew, Inc.
Hearing Loss
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided…
- Trial name
- NCT04041700
- Testing
- Osia 2 system
- Where
- 3 sites in Australia, Hong Kong
- Volunteers
- 29 people
- Sponsor
- Cochlear
Diabetic Macular Edema
A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated
This study will evaluate the efficacy and safety of OZURDEX in patients with Diabetic Macular Edema when used in a real world setting in Spain and Portugal.
- Trial name
- EYEberia (NCT03953807)
- Testing
- Dexamethasone Intravitreal Implant
- Where
- 26 sites in Portugal, Spain
- Volunteers
- 82 people
- Sponsor
- Allergan
Total Knee Arthroplasty, Osteoarthritis
A Study to Compare the NexGen CR and CR-Flex Knee Implants
The purpose of this study is to test for significant differences in functional outcomes, specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a NexGen CR-Flex knee implant.
- Trial name
- NCT00761956
- Testing
- NexGen CR-Flex Fixed Bearing Knee, NexGen CR Knee
- Where
- 8 sites in United States
- Volunteers
- 189 people
- Sponsor
- Zimmer Biomet
Breast Implantation
Retrospective Study of Incidence and Etiology of Reoperation After Primary Augmentation With Natrelle® Breast Implants
Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)
- Trial name
- RANBI (NCT02132572)
- Testing
- BIOCELL™ Textured 410 Implant
- Where
- 5 sites in France, Germany and 3 more
- Volunteers
- 201 people
- Sponsor
- Allergan
Elbow Injury
MDR ExploR Radial Head System PMCF
The objective of this retrospective and prospective consecutive series PMCF study is to collect long-term data confirming safety, performance and clinical benefits of the ExploR Radial Head System (implants and instrumentation)…
- Trial name
- NCT05583448
- Testing
- ExploR Radial Head
- Where
- 2 sites in United States, Norway
- Volunteers
- 93 people
- Sponsor
- Zimmer Biomet
Heart Failure
One Day Implantation Program for Heart Failure Patients Implanted With CRT-P
This study has been implemented to evaluate cardiac resynchronization therapy pacemaker (CRT-P) implantations on a same-day basis
- Trial name
- OEDIPE-CRT-P (NCT05142293)
- Testing
- Ambulatory procedure
- Where
- 19 sites in France
- Volunteers
- 354 people
- Sponsor
- Biotronik SE & Co. KG
Macular Edema
Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
This study will evaluate the safety, tolerability and efficacy of AR-1105 (dexamethasone implant) for the treatment of macular edema (ME) due to retinal vein occlusion (RVO).
- Trial name
- NCT03739593
- Testing
- AR-1105-CF1, AR-1105-CF2
- Where
- 11 sites in United States
- Volunteers
- 49 people
- Sponsor
- Aerie Pharmaceuticals
Dental Implant
Assessing Current Clinical Concepts in Dental Practice
This purpose of this database is to collect, store and use appropriately derived data from routine patient care in a specialist dental practice.
- Trial name
- NCT03003052
- Testing
- Dental implants
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- The Campbell Clinic, UK
Implantable Cardioverter Defibrillator(ICD)
To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP)
To compare Treatment Group (settings of Early Multiple ATP) and Control Group (settings of extended detection time for the conventional ATP) in Japanese patients, and confirm their safety and efficacy
- Trial name
- BIO|ATP (NCT05426785)
- Testing
- 1:1 ratio for Treatment Group and Control Group
- Where
- Japan
- Volunteers
- 398 people
- Sponsor
- Biotronik SE & Co. KG
Deficiency of Alveolar Ridge (Disorder), Alveolar Bone Grafting
Safety and Efficacy Evaluation of the Ivory Dentin Graft Device (IvoryGraft) - Long Term Follow-Up
long-term safety and performance of Ivory Dentin Graft. Ivory Dentin Graft is at least as good as the competitor treatment group (OsteoBiol Gen-Os) for alveolar ridge preservation following tooth extraction.
- Conditions
- Deficiency of Alveolar Ridge (Disorder), Alveolar Bone Grafting, Mandibular Prosthesis User
- Trial name
- NCT04868825
- Testing
- Ivory Dentin Graft, OsteoBiol Gen-Os
- Where
- Israel
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Ivory Graft Ltd.
Rheumatoid Arthritis
The SetPoint System Safety & Performance Post-Approval Study
Prospective, multicenter, post-market, registry study designed to systematically collect real-world data (RWD) from participants implanted with the SetPoint System [implanted, vagus-mediated, neuroimmune modulator] for the…
- Trial name
- ACTIVATE (NCT07489326)
- Testing
- SetPoint System
- Volunteers
- 150 people
- Sponsor
- SetPoint Medical Corporation
Temporomandibular Joint Disorders
Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
This is a long-term (10 years), retrospective-prospective, observational, single-arm, monocenter study of patients to be treated with the Materialise TMJ Total Arthroplasty System for TMJ replacement.
- Trial name
- NCT06951178
- Testing
- TMJ Total Arthroplasty System (TMJ System)
- Where
- Denmark
- Volunteers
- 30 people
- Sponsor
- Materialise
Hearing Loss, Binaural, Cochlear Implantation
Mi2000 TICI Follow-up
This Post-Market Clinical Follow-up (PMCF) investigation aims to further collect evidence on safety and performance of the Mi2000 TICI.
- Trial name
- M2FU (NCT07902414)
- Testing
- Cochlear Implantation
- Where
- 6 sites in Austria, Belgium and 2 more
- Volunteers
- 36 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
The goal of this observational study is to collect information on the safety and performance of the remedē System in patients with central sleep apnea who are undergoing the remedē System implant procedure.
- Conditions
- Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome, Central Sleep Apnea, Phrenic Nerve Stimulation
- Trial name
- ROSTER (NCT07907068)
- Testing
- Phrenic nerve stimulation
- Volunteers
- 300 people
- Sponsor
- Zoll Medical Corporation
Middle Ear Disease
Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts
Prospectively analyze the use of 3D subtraction CAD/CAM in the operating room environment. Study participants, requiring middle ear surgery and ossicular reconstruction, will be implanted with one of two middle ear implants.
- Trial name
- NCT03297736
- Testing
- 3D CAD/CAM autograft prosthesis, Control device
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Nitinetics LLC
Insufficient Bone Mass in the Maxilla for Dental Implants
Clinical Investigation to Assess the Safety and Feasibility of the Crestal, Minimal-invasive Sinus Floor Augmentation With the Pressure Chamber Drill (DKK) and the Sinus Vibration Pump (SVP)
The success of dental implants is based on a variety of factors including; surgical technique, health of the patient, operator skill and, to a significant part, sufficient bone for the placement and integration of dental…
- Trial name
- DKK SVP (NCT01204424)
- Testing
- minimal-invasive sinus floor augmentation with the DKK and SVP (JEDER Syst.), minimal invasive crestal sinus lift with the JEDER Systh.
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- Jeder GmbH
Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation
Clinical Investigation of the Medtronic Concerto™ Device
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- NCT00268320
- Testing
- Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator
- Where
- 51 sites in United States, Austria and 10 more
- Volunteers
- 270 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure