Clinical trials: Implants
Parkinson Disease
Clinical Evaluation of the Infinity Deep Brain Stimulation System
The purpose of this post-market study is to characterize the clinical performance of the Infinity Deep Brain Stimulation (DBS) system, including the Implantable Pulse Generator (IPG), directional DBS leads, extensions, iPad…
- Trial name
- PROGRESS (NCT02989610)
- Testing
- Omnidirectional stimulation, Directional stimulation
- Where
- 41 sites in United States, Australia and 6 more
- Volunteers
- 234 people
- Sponsor
- Abbott Medical Devices
Microtia
Long-Term Follow-Up Study of Unilateral Microtia Patients Implanted With AUR-201
Long-term follow-up of unilateral microtia patients implanted with AUR-201.
- Trial name
- AUR-201 (NCT06078566)
- Testing
- AUR-201
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Auregen Biotherapeutics, SA
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, Sensorineural
Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults
The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor
- Trial name
- SME (NCT03007472)
- Testing
- CI532, Nucleus 7
- Where
- 10 sites in United States
- Volunteers
- 96 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural, Cochlear Implant
MED-EL Remote Care Multi-Center Feasibility Study
MED-EL Remote Care is a way for MED-EL cochlear implant users to check their hearing and cochlear implant device from any location, without the need for a scheduled, in-person appointment with their audiologist.
- Conditions
- Hearing Loss, Sensorineural, Cochlear Implant, Cochlear Implant Recipients, Hearing Disorders
- Trial name
- NCT05973669
- Testing
- MED-EL Remote Care
- Where
- 5 sites in United States, Canada
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Med-El Corporation
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
Chondral or Osteochondral Lesion of Medial Femoral Condyle, Chondral or Osteochondral Lesion of Lateral Femoral Condyle
BiPhasic Cartilage Repair Implant (BiCRI) IDE Clinical Trial - Taiwan
The purpose of this trial is to evaluate the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI) compared to marrow stimulation in the treatment of chondral and osteochondral lesions located on the medial…
- Conditions
- Chondral or Osteochondral Lesion of Medial Femoral Condyle, Chondral or Osteochondral Lesion of Lateral Femoral Condyle, Chondral or Osteochondral Lesion of Trochlea
- Trial name
- NCT01477008
- Testing
- BiPhasic Cartilage Repair Implant, Marrow Stimulation
- Where
- 11 sites in Taiwan
- Volunteers
- 92 people
- Sponsor
- BioGend Therapeutics Co.Ltd
Conductive Hearing Loss
Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System
An international multicentre, open, comparative, parallel group, prospective clinical investigation with a single 5 year follow up visit.
- Trial name
- NCT02092610
- Testing
- Novel Implant BI300, Standard Implant BI300
- Where
- 4 sites in Netherlands, Sweden and 1 more
- Volunteers
- 77 people
- Sponsor
- Cochlear Bone Anchored Solutions
Presbyopia
Clinical Outcomes of Femtosecond Laser Presbyopia Treatment in Monofocal IOLs
This study aimed to assess the safety and efficacy of treating presbyopia in eyes implanted with a mono focal IOL using a low-energy femtosecond laser.
- Trial name
- NCT07384182
- Testing
- Perfector
- Where
- Czechia
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Perfect Lens, LLC
Coronary Artery Disease, Myocardial Ischemia
The eSVS® Mesh Randomized Post-Market Study
The purpose of this study is to evaluate patency rates of the external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Grafts (SVG) and Control SVG at 3-6 months and 24 months.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases
- Trial name
- NCT01462721
- Testing
- eSVS® Mesh
- Where
- Germany
- Volunteers
- 12 people
- Sponsor
- Kips Bay Medical, Inc.
Malignant Glioma
Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)
Post-marketing surveillance to investigate the clinical safety and effectiveness in patients of all implantation of Gliadel with malignant glioma in the actual medical setting.
- Trial name
- NCT02300532
- Testing
- No intervention
- Where
- 2 sites in Japan
- Volunteers
- 561 people
- Sponsor
- Eisai Co., Ltd.
Severe to Profound Mixed Hearing Loss
Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs
The purpose of this study is to evaluate the effect of the sound processor upgrade from the C-DACS investigational device Freedom sound processor to the Nucleus® CP810 sound processor for the Codacs™ system on the speech…
- Trial name
- NCT02156167
- Testing
- CP810 and Codacs™ system test
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Cochlear
Inguinal Hernia, Postoperative Pain
Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair
A multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years of age, and 2 to <6 years of age who are scheduled for elective open inguinal hernia repair.
- Trial name
- NCT03262688
- Testing
- Bupivacaine HCl collagen-matrix implant, Bupivacaine HCl infiltration
- Where
- 11 sites in United States
- Volunteers
- 159 people
- Sponsor
- Innocoll
Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
S-ICD® System Post Approval Study
The purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting.
- Trial name
- NCT01736618
- Testing
- S-ICD System
- Where
- 87 sites in United States
- Volunteers
- 1,766 people
- Sponsor
- Boston Scientific Corporation
Venous System, Venous Access
A Retrospective, Observational, Monocenter, Study to Describe the Utilization and Overall Safety and Performance of POLYSITE®/SEESITE® Implantable Ports
This study is a retrospective, observational, monocenter case series. The purpose of this study is to collect clinical data to describe the use of POLYSITE® and SEESITE® devices and verify overall safety and performance.
- Conditions
- Venous System, Venous Access, Chemotherapy, Antibiotics
- Trial name
- NCT05519787
- Testing
- Central Veinous access devices' insertion
- Where
- France
- Volunteers
- 70 people
- Sponsor
- Perouse Medical
Hearing Loss
Bilateral Cochlear Implant Benefit in Young Children
The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of 60 children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in…
- Trial name
- NCT00424307
- Testing
- HiResolution Bionic Ear System
- Where
- 14 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Advanced Bionics
Central Precocious Puberty
Histrelin Subcutaneous Implant in Children With Central Precocious Puberty
The purpose of this study is to follow and collect additional medical and developmental information on children after histrelin subcutaneous implant therapy is discontinued.
- Trial name
- NCT00779103
- Testing
- Histrelin Subcutaneous Implant
- Volunteers
- 36 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Hearing Loss
Usability of the CP950 Sound Processor
Studying usability and gaining feedback of the CP950 Sound Processor in experienced cochlear implant recipients.
- Trial name
- C950 (NCT02727842)
- Testing
- CP950 Sound Processor, Wireless programming pod
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Cochlear
Hearing Loss
N6 Input Processing in Traditional CI Recipients
The purpose of this study is to evaluate the enhanced signal processing features of the Nucleus 6 Sound Processor on existing Nucleus cochlear implant recipients currently using the Nucleus 5 Sound Processor.
- Trial name
- NCT02239263
- Testing
- Nucleus 6 Sound Processor
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Cochlear
Surgery
Prospective, Multicenter Observational Study Evaluating the Long Term Safety of the Custombone Implant
A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™ The patients will be included as soon as they…
- Trial name
- CUSTOMBONE (NCT01824706)
- Testing
- craniectomy
- Where
- 18 sites in France
- Volunteers
- 110 people
- Sponsor
- Integra LifeSciences Corporation