Clinical trials: Implants
Hearing Loss, Binaural, Cochlear Implantation
Mi2000 TICI - Post-market Implantation Study
This Post-Market Clinical Follow-up (PMCF) investigation aims to further collect evidence on safety and performance of the Mi2000 TICI.
- Trial name
- TUPIS (NCT07897318)
- Testing
- Cochlear Implantation
- Volunteers
- 22 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Arrhythmia, Cardiovascular Diseases
Diagnostic Investigation of Sudden Cardiac Event Risk
The overall objective of the DISCERN study is to develop and validate a genomic diagnostic assay to identify patients at increased risk for lethal ventricular arrhythmias and sudden cardiac death (SCD).
- Conditions
- Arrhythmia, Cardiovascular Diseases, Heart Failure, CVD
- Trial name
- DISCERN (NCT00500708)
- Where
- 8 sites in United States
- Volunteers
- 1,564 people
- Sponsor
- CardioDx
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
Chronic Sinusitis
Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia
This is a feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis patients undergoing sinus surgery of peripheral sinus…
- Trial name
- EXCEED (NCT02228720)
- Testing
- Propel Nova Sinus Implant
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Intersect ENT
Lung Cancer, Lung Cancer Stage I
Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
This is a feasibility study to determine the usefulness of a brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit lung cancer patients by reducing…
- Conditions
- Lung Cancer, Lung Cancer Stage I, Lung Cancer Stage II
- Trial name
- NCT03290534
- Testing
- CivaSheet
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- CivaTech Oncology
GERD
Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants for the Treatment of GERD
The purpose of this study was to evaluate the safety and efficacy of placing multiple transmural sutures for the treatment of GERD.
- Trial name
- NCT00586859
- Testing
- NDO Full-thickness Plicator
- Where
- 4 sites in Germany
- Volunteers
- 41 people
- Sponsor
- NDO Surgical, Inc.
Prostate Cancer
Real-life Study of Patients After 3-months of Leuprorelin 5mg Implant in Prostate Cancer
To improve the management of patients suffering from prostate cancer, Laboratoires BOUCHARA-RECORDATI wish to set up an observational study to document, in daily practice, and over a large population, the profile and clinical and…
- Trial name
- LEPTO (NCT03990194)
- Testing
- Leuprolide Acetate
- Sponsor
- RECORDATI GROUP
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
ICD, Cardiomyopathy Ischemic
Assessment of Risk Factors for Appropriate ICD (Implantable Cardioverter-defibrillator) Intervention in Patients With Ischemic Cardiomyopathy
Design: PARCADIA is a prospective non-randomized non-interventional multi-center clinical investigation in Europe. Patients with depressed LV (left ventricular) function assessed on local standards, of ischemic origin and on…
- Conditions
- ICD, Cardiomyopathy Ischemic, Primary Prevention
- Trial name
- PARCADIA (NCT04014946)
- Testing
- ICD implantation
- Volunteers
- 200 people
- Sponsor
- Biotronik SE & Co. KG
Peri-implant Mucositis
The Efficacy of Stabilized Chlorine Dioxide Rinse as a Chemical Adjuvant for Treatment of Per-implant Mucositis
A full understanding of etiology and diagnosis of peri-implant diseases is crucial for finding effective treatments for these diseases that are more widely accessible to dentists.
- Trial name
- NCT04838054
- Testing
- Stabilized chlorine dioxide oral rinse
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Rowpar Pharmaceuticals, Inc.
Cataract, Refractive Lens Exchange
Visual Performance of Patients Implanted With a Multifocal IOL
The goal of this clinical trial is to learn about the visual performance of a new multifocal intra-ocular lens in patients presenting for cataract or refractive lens exchange surgery.
- Trial name
- VISUAL (NCT06111222)
- Testing
- AT ELANA
- Where
- 3 sites in Germany, Spain
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Carl Zeiss Meditec AG
Erythropoietic Protoporphyria
Multicentre Phase III Erythropoietic Protoporphyria Study
This was a phase III, multicentre, randomised, double-blind, placebo-controlled study, to evaluate the safety and efficacy of subcutaneous bioresorbable afamelanotide implants in patients with Erythropoietic Protoporphyria (EPP).
- Trial name
- NCT04053270
- Testing
- Afamelanotide
- Volunteers
- 100 people
- Sponsor
- Clinuvel Pharmaceuticals Limited
Jaw, Edentulous
Study on ASTRA TECH Implant System, OsseoSpeed™ Implants in Patients Missing All Teeth in the Upper Jaw, Restored With Provisional Teeth Within 24 Hours
The purpose of the study is to evaluate ASTRA TECH Implant System, OsseoSpeed™ implants, in patients with totally edentulous upper jaws and poor bone quality and quantity, when provisional artificial teeth are attached within 24…
- Trial name
- NCT00711022
- Testing
- ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
- Where
- 2 sites in United States, Sweden
- Volunteers
- 51 people
- Sponsor
- Dentsply Sirona Implants and Consumables
Prostate Cancer
Pilot Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects
Primary Goal The study's primary goal is to assess the safety of the BioProtect biodegradable balloon implant and implantation procedure, in prostate cancer subjects undergoing routine radiation therapy (XRT) treatment.
- Trial name
- NCT00918229
- Testing
- balloon implant, Balloon implantation
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- BioProtect
Total Knee Arthroplasty (Postoperative Pain)
Phase 2B Study Assessing Pain Relief After Replacement of the Knee
The goal of the ATX101-TKA-004 clinical trial aims to evaluate the efficacy and safety of ATX101 1,500 mg in participants undergoing primary unilateral total knee arthroplasty.
- Trial name
- SPARK2 (NCT06799845)
- Testing
- ATX101, bupivacaine hydrochloride
- Where
- 11 sites in United States
- Volunteers
- 226 people
- Sponsor
- Allay Therapeutics, Inc.
Hallux Valgus
Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device
The Nexis® screw system is a range of osteosynthesis screws for the foot. Nexis® Bunion Screws are Class IIb implantable medical devices.
- Trial name
- PECA (NCT05361317)
- Testing
- Nexis® PECA Bunion device
- Where
- 4 sites in France
- Volunteers
- 86 people
- Sponsor
- Novastep
Ocular Hypertension, Open Angle Glaucoma
CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension
To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.
- Trial name
- NCT04360174
- Testing
- OTX-TIC
- Where
- 5 sites in United States
- Volunteers
- 19 people
- Sponsor
- Ocular Therapeutix, Inc.
Femur Fracture, Osteotomy
ZNN Bactiguard Antegrade Femoral Nails PMCF Study
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Antegrade Femoral Nails. The objective of this study is to collect data confirming the safety, performance, and clinical…
- Trial name
- NCT05339360
- Testing
- Femoral fixation with intramedullary nails
- Where
- 2 sites in Spain, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
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
Arrhythmias, Cardiac, Bradycardia
Cardiac Implantable Electronic Device (CIED) Research Study
The study is designed to collect data on Cardiovascular Implantable Electronic Device (CIED) information, implant procedure details, and/or patient characteristics to support development of future CIED products and procedures.
- Conditions
- Arrhythmias, Cardiac, Bradycardia, Tachycardia
- Trial name
- NCT05061862
- Testing
- cardiac implantable electronic devices (CIEDs)
- Where
- 9 sites in United States, Belgium
- Volunteers
- 1,000 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure