Clinical trials: Implant
Cranioplasty, Craniofacial Abnormalities
Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
The purpose of this study is to confirm the safety, performance and effectiveness of Stryker's PEEK Customized Implants when used for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and…
- Conditions
- Cranioplasty, Craniofacial Abnormalities, Craniofacial Injuries
- Trial name
- NCT05362370
- Testing
- Stryker's PEEK Customized Implant
- Where
- 13 sites in United States, Austria and 4 more
- Volunteers
- 99 people
- Sponsor
- Stryker Craniomaxillofacial
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
Noninfectious Posterior Uveitis
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants
This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide (FA) intravitreal implants for the management of subjects with non-infectious uveitis affecting the…
- Trial name
- NCT00407082
- Testing
- fluocinolone acetonide intravitreal implant, Fluocinolone acetonide 2.1mg
- Where
- United States
- Volunteers
- 278 people
- Sponsor
- Bausch & Lomb Incorporated
Aortic Stenosis
PARTNER II Trial: S3iCAP
Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.
- Trial name
- PII S3i CAP (NCT02687035)
- Testing
- SAPIEN S3 valve
- Where
- 56 sites in United States, Canada
- Volunteers
- 1,822 people
- Sponsor
- Edwards Lifesciences
Cartilage Disease
Non-interventional Study With NOVOCART® Inject in the Reconstruction of the Knee Cartilage Defects
Retrospective non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full-thickness cartilage defects in the knee joint.
- Trial name
- RENOVO (NCT02941120)
- Where
- 7 sites in Germany
- Volunteers
- 245 people
- Sponsor
- Tetec AG
Pectus Excavatum
Pectus Excavatum Camouflage (IT)
The clinical study evaluates the use of a custom-made medical-grade polycaprolactone-PCL Pectus scaffold implantation with Autologous Fat Grafting for pectus excavatum camouflage (IT).
- Trial name
- NCT05634070
- Testing
- PCL Pectus scaffold implantation and autologous fat grafting
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- BellaSeno GmbH
Non-infectious Uveitis
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy
This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to…
- Trial name
- NCT00468871
- Testing
- fluocinolone acetonide intravitreal implant, corticosteroids and immunosuppressants
- Volunteers
- 140 people
- Sponsor
- Bausch & Lomb Incorporated
Pre-existing Condition
PMEI Post-Market Clinical Follow-Up
Confirm safety and performance of passive middle ear implants (PMEIs) in subjects with pre-existing condition which made the implantation of a MED-EL PMEI necessary
- Trial name
- NCT05565339
- Testing
- PMEIs
- Where
- 11 sites in Austria, Germany and 1 more
- Volunteers
- 497 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Presbyopia
Safety and Efficacy of an Intrastromal Transform™ Corneal Allograft (TCA) for Presbyopia Correction
The objective of this clinical study is to evaluate the safety and effectiveness of intrastromal implantation of the Allotex TransForm corneal allograft (TCA) for improving near vision in presbyopic subjects.
- Trial name
- NCT03671135
- Testing
- TCA Intrastromal Inlay
- Where
- 4 sites in Belgium, Ireland and 1 more
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Allotex, Inc.
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
BD SiteRite 9 for VAD Insertion
BD SiteRite(TM) 9 Ultrasound System - Clinical Study
This post-market study is being conducted to generate safety and performance data on the SiteRite 9 System. The data will be utilized to support regional registrations (for example, EU MDR), and document any unforeseen residual…
- Trial name
- NCT06632509
- Testing
- BD SiteRite(TM) 9
- Where
- United States
- Volunteers
- 149 people
- Sponsor
- Becton, Dickinson and Company
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
Symptomatic Cartilage Defects of the Femoral Condyle
Comparison of BioCart™II With Microfracture for Treatment of Cartilage Defects of the Femoral Condyle
BioCart™II is a novel scaffold seeded with autologous chondrocytes to be used to repair cartilage lesions of the knee. This study is designed to compare the efficacy and safety of BioCart™II treatment compared to microfracture…
- Trial name
- NCT00729716
- Testing
- BioCart™II, Microfracture
- Where
- 8 sites in United States, Israel
- Volunteers
- 40 people
- Sponsor
- ProChon Biotech Ltd
Adverse Effect of MRI on an Implanted Pacemaker Lead, Adverse Effect of MRI on an Implanted Pacemaker
Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI…
- Trial name
- NCT01576016
- Testing
- Accent MRI system (lead safety), Accent MRI system (with MRI scan)
- Where
- 70 sites in United States, Australia and 3 more
- Volunteers
- 950 people
- Sponsor
- Abbott Medical Devices
MPS I
Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-318 in Subjects With MPS I
The purpose of the study is to evaluate the safety, tolerability of ascending doses of SB-318. SB-318 is an intravenously delivered Zinc Finger Nuclease (ZFN) Therapeutic for genome editing.
- Trial name
- NCT02702115
- Testing
- SB-318
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Sangamo Therapeutics
Sensorineural Hearing Loss, Bilateral, Cochlear Implant
Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
- Trial name
- NCT03304106
- Testing
- Commercially available cochlear implant and AI system
- Where
- 9 sites in United States
- Volunteers
- 102 people
- Sponsor
- Cochlear
Inflammation, Uveitis
Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant
Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants
- Trial name
- NCT01060787
- Testing
- Fluocinolone Acetonide 0.59 mg, Fluocinolone Acetonide 2.1 mg
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- Bausch & Lomb Incorporated
Aortic Stenosis
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe…
- Trial name
- REPRISE III (NCT02202434)
- Testing
- Lotus Valve System, CoreValve/Evolut R Transcatheter Aortic Valve Replacement System, LOTUS Edge Valve System
- Where
- 58 sites in United States, Australia and 4 more
- Volunteers
- 1,425 people
- Sponsor
- Boston Scientific Corporation
Cerebral Palsy
Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With CP
Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP
- Trial name
- CP (NCT03979898)
- Testing
- ASTROSTEM
- Where
- South Korea
- Volunteers
- 1 people
- Sponsor
- R-Bio
Mucopolysaccharidosis II, MPS II
Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-913 in Subjects With MPS II
The purpose of the study is to evaluate the safety, tolerability and effect on leukocyte and plasma Iduronate 2-Sulfatase (IDS) enzyme activity of ascending doses of SB-913.
- Trial name
- NCT03041324
- Testing
- SB-913
- Where
- 5 sites in United States
- Volunteers
- 9 people
- Sponsor
- Sangamo Therapeutics