Clinical trials: Implants
Degenerative Disc Disease
Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion
This is a retrospective clinical study (chart review) of patients who have previously undergone Transforaminal Lumbar Interbody Fusion or Posterior Lumbar Interbody Fusion surgery with the FlareHawk expandable interbody fusion…
- Trial name
- NCT04057235
- Testing
- FlareHawk Interbody Fusion System
- Where
- 3 sites in United States
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- Integrity Implants Inc.
Chronic Sinusitis, Nasal Polyps
Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps
The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic sinusitis patients with recurrent nasal polyps.
- Trial name
- RESOLVE (NCT01732536)
- Testing
- S8 Sinus Implant, Mometasone furoate nasal spray
- Where
- 19 sites in United States
- Volunteers
- 100 people
- Sponsor
- Intersect ENT
Knee Prosthesis, Knee Arthroplasty
Comparison of Kinematics for Subjects Implanted With a PFC Sigma Rotating Platform or Fixed Bearing TC3 Prosthesis
The objectives of this study are four-fold: 1. To determine the three-dimensional, in vivo kinematics for subjects having either a fixed- or mobile-bearing Press Fit Condylar (PFC) Sigma Total Condylar III Prosthesis, comparing…
- Trial name
- PFC & TC3 (NCT01290640)
- Testing
- DePuy fixed-bearing Total Condylar III (TC3) TKA, DePuy PFC Rotating Platform TC3 TKA
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- The University of Tennessee, Knoxville
Glaucoma
Early Feasibility Study of the Brown Glaucoma Implant in Patients With Severe Visual Impairment or No Light Perceived
This is a prospective, non-randomized, single-arm early feasibility study to assess the safety and feasibility of lowering intraocular pressure with the Brown Glaucoma Implant.
- Trial name
- Early Bird (NCT03469297)
- Testing
- Brown Glaucoma Implant
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- MicroOptx
Wound, Cardiac Arrhythmia
ZIPS Study - Zip Incision aPproximation vs. Suture
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair.
- Trial name
- ZIPS (NCT02213510)
- Testing
- Zip Surgical Skin Closure Device, Standard Suture Closure
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of California, San Diego
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
Hearing Loss, Sensorineural
Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients
This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.
- Trial name
- DUAL (NCT06298396)
- Testing
- Program using default MAP, Program using low-power 1 (LP1) MAP, Program using low-power 2 (LP2) MAP
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- Cochlear
Aortic Valve Disease, Aortic Stenosis
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively.
- Trial name
- PERSIST-AVR (NCT02673697)
- Testing
- Perceval valve, other stented biological valve
- Where
- 47 sites in United States, Austria and 10 more
- Volunteers
- 914 people
- Sponsor
- Corcym S.r.l
Implantable Defibrillator User
A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study
To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.
- Trial name
- MRI Ready IDE (NCT02787291)
- Testing
- Ellipse VR ICD and Durata/Optisure lead
- Where
- 32 sites in United States, Hungary and 3 more
- Volunteers
- 227 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain
The primary objective of this study is to investigate patient satisfaction with treatment using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs.
- Trial name
- NCT01665040
- Testing
- Neurostimulation device implantation
- Where
- 7 sites in Australia, Belgium and 1 more
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
Non-valvular Atrial Fibrillation (AF)
Watchman FLX Pro CT Pilot Study
The primary objective of this study is to measure device tissue coverage post-implantation of the WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device (WATCHMAN FLX Pro) using the serial advanced imaging modalities of…
- Trial name
- NCT05567172
- Testing
- Left atrial appendage closure device WM FLX Pro
- Where
- Denmark
- Volunteers
- 43 people
- Sponsor
- Boston Scientific Corporation
Retinitis Pigmentosa
Argus® II Retinal Stimulation System Feasibility Protocol
Investigational Phase of the Study: The objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with retinitis…
- Trial name
- NCT00407602
- Testing
- Implant of Argus II Retinal Prosthesis
- Where
- 12 sites in United States, France and 3 more
- Volunteers
- 30 people
- Sponsor
- Second Sight Medical Products
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
Heart Disease, Cardiovascular Disease
Remote Device Interrogation In The Emergency Department
A prospective, post market, non-randomized study to evaluate the reduction in time to interrogation for patients with St. Jude Medical remote care compatible devices interrogated by the unpaired Merlin@home transmitter in the…
- Conditions
- Heart Disease, Cardiovascular Disease, Heart Failure, Arrhythmias, Cardiac
- Trial name
- REMEDY (NCT01871090)
- Testing
- Unpaired remote monitoring transmitter
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Abbott Medical Devices
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
Proximal Humeral Fracture, Proximal Tibia Fractures
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System
The study is a monocentric, retro- and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the Zimmer® Plates…
- Conditions
- Proximal Humeral Fracture, Proximal Tibia Fractures, Diaphyseal Fracture
- Trial name
- NCT05215613
- Where
- Italy
- Volunteers
- 57 people
- Sponsor
- Zimmer Biomet
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
Contraception, Unintended Pregnancy
Innovative Model of Patient-Centered ConTraception
This study is testing models of contraceptive care that were developed as part of the Contraceptive CHOICE Project. CHOICE is a prospective cohort study of 9,256 women designed to: 1) promote the use of long-acting reversible…
- Trial name
- IMPACCT (NCT02364037)
- Testing
- CHOICE Project Structured Contraceptive Counseling, Contraceptive Education Session, Cost Support for IUDs and implants
- Where
- 3 sites in United States
- Volunteers
- 1,008 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Macular Edema, Diabetes Mellitus
A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
There is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery.
- Trial name
- NCT01673191
- Testing
- Dexamethasone intravitreal implant, Steroid plus NSAID eye drop combination therapy
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Retinal Consultants of Arizona
Ear Diseases, Hearing Loss, Bilateral
Lumity CI Study - Clinical Evaluation of Next Generation Cochlear Implant Sound Processor
This is a prospective within-subjects repeated-measures study that will enroll 18 bilateral adult users implanted with a HiResolution Bionic Ear System (HiRes 90KTM, HiRes 90K TM Advantage, HiResTM Ultra, HiResTM Ultra 3D and CII…
- Conditions
- Ear Diseases, Hearing Loss, Bilateral, Otorhinolaryngologic Diseases
- Trial name
- NCT06858826
- Testing
- Control cochlear implant sound processor, Next Generation Sound Processor
- Volunteers
- 20 people
- Sponsor
- Advanced Bionics