Clinical trials: Implants
Diabetes Mellitus, Diabetes Mellitus, Type 1
PRECISION Study: Multi-center Study of Performance of a Novel Implanted CGM System Using a Next Generation Transmitter and Algorithm
The purpose of this multi-center, prospective clinical study is to evaluate the performance of a novel, implanted Senseonics continuous glucose monitoring system (Senseonics CGM System) compared to Yellow Springs Instrument (YSI)…
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- PRECISION (NCT03251079)
- Testing
- Continuous glucose monitoring system
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Senseonics, Inc.
Urinary Retention, Underactive Bladder
Previously Implanted Pudendal Nerve Stimulation
This study seeks to examine the response of the bladder to different pudendal nerve stimulation frequencies, by studying patients who have been previously-implanted with pudendal nerve neurostimulators.
- Trial name
- NCT04473469
- Testing
- Medtronic Interstim II Model 3058 Neurostimulator
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Michigan
Chronic Rhinosinusitis (Diagnosis)
A Clinical Evaluation of PROPEL® Contour Sinus Implant
The objective of this study is to evaluate the efficacy of PROPEL Contour placement following an in-office frontal sinus balloon dilation (SBD) in patients with chronic rhinosinusitis (CRS)
- Trial name
- EXPAND (NCT04858802)
- Testing
- PROPEL Contour Sinus Implant, Balloon Sinus Dilation Alone
- Where
- 14 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Intersect ENT
Ventricular Tachycardia, Ventricular Fibrillation
Pediatric Lead Extractability and Survival Evaluation (PLEASE)
This is a randomized, prospective clinical trial comparing 2 different types of implantable cardioverter defibrillator (ICD) leads in children and patients with congenital heart disease.
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Cardiomyopathy, Long QT Syndrome
- Trial name
- NCT00335036
- Testing
- ICD lead implant, Thin leads
- Where
- United States
- Volunteers
- 748 people
- Sponsor
- Charles Berul
Adhesive Dental
Immediate Placement and Stabilization of Dental Implants With Tetranite Stabilization Material in Mandibular and Maxillary Tooth Extraction Sites That Fail to Provide Adequate Primary Stability
This study is to determine if a new bone adhesive is useful in stabilizing dental tooth implants. Data collected from the study will examine the strength, performance, and the safety of the material.
- Trial name
- NCT04121364
- Testing
- Tetranite
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- RevBio
Jaw, Edentulous, Partially
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
The purpose of this study is to evaluate the clinical outcome of implant survival of the PrimeTaper EV implant in single tooth restorations 1 year after permanent restoration.
- Trial name
- NCT05315414
- Testing
- PrimeTaper EV implant
- Where
- 5 sites in United States, Belgium and 3 more
- Volunteers
- 138 people
- Sponsor
- Dentsply Sirona Implants and Consumables
Hearing Loss
Multi-center Study to Examine Changes to the Environment Surrounding the Electrodes in the Cochlea and to Capture the Most Challenging Listening Environments Experienced by Persons With a Cochlear Implant
This early feasibility study aims to collect pilot data on impedance measurements in real-world environments and to collect real-world and difficult listening situations and the factors impacting this, reflecting situations the…
- Trial name
- DICE (NCT06173687)
- Testing
- The impedance measurement task using the Mobile Research App (MRA)
- Where
- 4 sites in Australia, Belgium and 1 more
- Volunteers
- 51 people
- Sponsor
- Cochlear
Benign Prostate Hyperplasia
Pivotal Study to Assess the Safety and Effectiveness of the iTind Device
The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as compared to control group (catheter only).
- Trial name
- NCT02506465
- Testing
- iTIND
- Where
- 13 sites in United States, Canada
- Volunteers
- 185 people
- Sponsor
- Medi-Tate Ltd.
Dental Implants
Mandibular Overdenture Clinical Trial Comparing Parallel Sided and Tapered Dental Implants
The purpose of the study is to compare two different types of dental implants which will be used to support/retain a removable denture in the edentulous mandible.
- Trial name
- NCT03272828
- Testing
- Nobel Biocare titanium dental implants
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University of Washington
High Frequency Sensorineural Hearing Loss
Hybrid L24 New Enrollment Post Approval Study
This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.
- Trial name
- HNE (NCT02379819)
- Testing
- Nucleus Hybrid L24 Implant
- Where
- 19 sites in United States
- Volunteers
- 52 people
- Sponsor
- Cochlear
Hernia Repair With Compartment Syndrome
Feasibility Study of The Use of FLEX HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrix in The Closure of Abdominal Wall Defects With Component Separation in Clean or Contaminated Cases
This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrixin the repair of hernias.
- Trial name
- Flex HD (NCT01597128)
- Testing
- Flex HD, Strattice
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- John Roth
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction
- Trial name
- NCT00689871
- Testing
- Natrelle(TM) Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 715 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Open Reduction and Internal Fixation of Extremity Fractures
MICRO Study: Detecting Bacterial Infections Related to Orthopaedic Surgical Implants
A prospective trial conducted at Shock Trauma of patients between 18 years of age and older who have sustained a fracture with metal implanted.
- Trial name
- MICRO (NCT03132246)
- Testing
- Blood draws
- Where
- United States
- Volunteers
- 260 people
- Sponsor
- University of Maryland, Baltimore
Patient and Surgical Related Risk Factors for Complications
TiLoop® Bra for Breast Reconstruction
A new approach for single stage implant based breast reconstruction (BR) is the use of a titanium-coated polypropylene mesh (TCPM) as an alternative to acellular dermal matrix (ADM).
- Trial name
- NCT01544023
- Volunteers
- 207 people
- Sponsor
- University of Rostock
Neoplasms, Benign, Neoplasms, Malignant
Oxygen Measurements in Subcutaneous Tumors by EPR Oximetry Using OxyChip
Tumors with low oxygen levels are associated with poor prognosis and resistance to standard radiotherapy or systemic therapies. The ability to make repeated oxygen measurements in tumors could be used to help select the most…
- Trial name
- NCT02706197
- Testing
- OxyChip
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Periannan Kuppusamy
Lumbar Post-Laminectomy Syndrome, Chronic Low Back Pain
Determining the Prognostic Value of Continuous Intrathecal Infusion
The purpose of this study will be to determine the efficacy and the prognostic value of a continuous intrathecal prognostic infusion test in an in-hospital setting for selecting patients who would have better long term outcomes…
- Conditions
- Lumbar Post-Laminectomy Syndrome, Chronic Low Back Pain, Vertebral Compression Fracture, Failed Back Surgery Syndrome
- Trial name
- NCT03523000
- Testing
- Continuous intrathecal prognostic infusion test, Bupivacaine, Fentanyl
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- University Hospitals Cleveland Medical Center
Spinal Tumor
A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy
The goal of the first part of this clinical research study is to learn how to deliver more accurate radiation treatment of tumors in the spine.
- Trial name
- NCT01624220
- Testing
- Spinal SBRT (Standard Dose), Spinal SBRT (Higher Dose), Gold Seed Implantation
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- M.D. Anderson Cancer Center
Total Knee Arthroplasty, Osteo Arthritis Knee
In Vivo Kinematics for Subjects Implanted With Klassic Total Knee Arthroplasty (TKA)
In vivo knee kinematics will be assessed for 20 subjects that have been implanted with a Total Joint Orthopedics Klassic knee system by Dr.
- Conditions
- Total Knee Arthroplasty, Osteo Arthritis Knee, Knee Implant, Knee Injuries
- Trial name
- TKA (NCT04113785)
- Testing
- Klassic Knee System
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- The University of Tennessee, Knoxville
Hearing Loss
Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults
Clinical study to evaluate the safety and efficacy of the Cochlear™ Nucleus® CI422 cochlear implant for new cochlear implant adult recipients with broader requirements to be considered an eligible candidate.
- Trial name
- NCT01867008
- Testing
- Nucleus CI422 Cochlear Implant with N6 Sound Processor
- Where
- 2 sites in United States
- Volunteers
- 55 people
- Sponsor
- Cochlear
Diabetic Macular Edema
Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.
- Trial name
- FAME (NCT00344968)
- Testing
- fluocinolone acetonide, Standard of care laser photocoagulation
- Where
- United States
- Volunteers
- 956 people
- Sponsor
- Alimera Sciences