Clinical trials: Implants
Heart Failure
BIOSTREAM.HF HeartInsight
The main goal is to learn how HeartInsight is used in clinical routine care. HeartInsight is a heart failure monitoring and notification tool within BIOTRONIK's Home Monitoring System.
- Trial name
- NCT05761249
- Testing
- HeartInsight activation
- Where
- 7 sites in Czechia, France and 3 more
- Volunteers
- 100 people
- Sponsor
- Biotronik SE & Co. KG
Analgesia After Pacemaker, AICDS Implantation Pediatrics
Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of Automatic Implantable Cardioverter Defibrillators (AICDs) and Pacemakers in Pediatric Patients
The purpose of this study is to determine the efficacy and safety of truncal blocks for pacemaker and Automatic Implantable Cardioverter Defibrillator implantation in children and to prospectively evaluate whether there is a…
- Trial name
- NCT04184349
- Testing
- LA group, B Group
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- The University of Texas Health Science Center, Houston
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
Heart Failure, Obesity
Safety of Body Composition Analysis in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs)
The purpose of this study is to define the safety of using bioimpedance for analysis of body composition in heart failure patients with ICD devices.
- Trial name
- NCT01568606
- Testing
- Body Composition Analysis InBody Scale
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, Los Angeles
Heart Failure
Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM)
The purpose of this study was to generate effectiveness data of Angiotensin receptor neprilysin inhibitor (ARNI), in the Chinese Heart failure with reduced ejection fraction (HFrEF) patients with implantable cardioverted…
- Trial name
- RHYTHM (NCT04491136)
- Testing
- ACEI/ARB, ARNI
- Where
- 23 sites in China
- Volunteers
- 201 people
- Sponsor
- Novartis Pharmaceuticals
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
Jaw, Edentulous
A Study to Treat Patients With Edentulous Mandibles With Two Straumann 3.3mm Diameter Bone Level Implants
The purpose of this study is to assess the change of crestal bone level at the Titanium Zirconium (TiZr) compared to Titanium (grade IV) implant between surgery and 6, 12, 24, and 36 month post surgery.
- Trial name
- NCT00905840
- Testing
- Titanium Zircon implant, Titanium Grade IV implant
- Where
- 8 sites in Belgium, Germany and 3 more
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Institut Straumann AG
Jaw, Edentulous, Partially
Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading
The purpose of this study is primarily to evaluate implant survival rate of Astra Tech Fixture ST placed in the posterior maxilla.
- Trial name
- NCT00748241
- Testing
- Astra Tech Fixture ST
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Dentsply Sirona Implants and Consumables
Hearing Loss
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided…
- Trial name
- NCT04041700
- Testing
- Osia 2 system
- Where
- 3 sites in Australia, Hong Kong
- Volunteers
- 29 people
- Sponsor
- Cochlear
Nasal Obstruction
LATERA-OFFICE Study
Prospective, multicenter, nonrandomized, single-arm controlled study to obtain outcomes data in participants with severe to extreme class NOSE scores who are undergoing placement of the Spirox Latera Implant with or without…
- Trial name
- NCT02964312
- Testing
- Nasal Implant
- Where
- 9 sites in United States
- Volunteers
- 166 people
- Sponsor
- Spirox, Inc.
Opioid-use Disorder
Pharmacokinetic Study of Vivitrol in Healthy Participants
This is a Phase I, single-center, single arm, open-label study, to establish the pharmacokinetic (PK) parameters of Vivitrol 380 mg IM injection (IP), a US Food and Drug Administration (FDA) approved medication.
- Trial name
- NCT04716881
- Testing
- Naltrexone 380 MG
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Go Medical Industries Pty Ltd
Implants, Cochlear, Child
Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants
The purpose of this feasibility study is to evaluate whether implantation of one Nucleus L24 electrode array and one FDA approved standard-length device in the contralateral ear can provide useful binaural hearing in pediatric…
- Conditions
- Implants, Cochlear, Child, Hearing Loss, Bilateral
- Trial name
- NCT03156465
- Testing
- Hybrid L24
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- University of Iowa
Myopia
Long Term Safety Protocol for the AcrySof CACHET Phakic Lens
The purpose of this long term safety study is to estimate the annualized endothelial cell loss (ECL) rate (for up to 10 years following date of implantation) of subjects previously implanted with the ACRYSOF CACHET Phakic…
- Trial name
- NCT01497067
- Testing
- ACRYSOF CACHET Phakic Lens (L-series)
- Where
- United States
- Volunteers
- 657 people
- Sponsor
- Alcon Research
Distal Radius Fracture, Distal Ulna Fracture
PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System
The study is a single-center, retrospective, 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 DVR Plates.
- Conditions
- Distal Radius Fracture, Distal Ulna Fracture, Osteotomy
- Trial name
- NCT04653051
- Where
- United Kingdom
- Volunteers
- 111 people
- Sponsor
- Zimmer Biomet
Arrhythmias, Cardiac
Reveal In-Office Implants
The purpose of this study is to gather evidence about the safety and feasibility of performing the implant procedure for the Reveal Insertable Cardiac Monitor (ICM) in an office or clinic setting rather than the traditional…
- Trial name
- NCT01168427
- Testing
- Reveal® DX or Reveal® XT Insertable Cardiac Monitor
- Where
- 9 sites in United States
- Volunteers
- 66 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
CareLink® Network Evaluation
The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in clinical practice in the country specific healthcare setting.
- Trial name
- NCT01023022
- Testing
- Medtronic CareLink® Network
- Where
- 10 sites in Poland
- Volunteers
- 176 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Soft Tissue
Customized Impressions in Dental Implants - Soft Tissues Changes
Six patients with a single unit implant in the anterior maxilla (from premolar to premolar), after at least 3 months with provisional implant supported restoration will be submitted to definitive implant impressions.
- Trial name
- NCT03496428
- Testing
- Dental implant impressions- Different Techniques
- Where
- Portugal
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Implantology Institute
Cervical Degenerative Disc Disease, Radiculopathy
An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine
This clinical study will assess the metal concentrations present in the blood serum of patients who receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7.
- Conditions
- Cervical Degenerative Disc Disease, Radiculopathy, Myelopathy
- Trial name
- NCT03062657
- Testing
- PRESTIGE LP™ Cervical Disc
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Medtronic Spinal and Biologics
Surgical Site Infection
Air Barrier System for the Prevention of Surgical Site Infection
Airborne particles are present in all indoor environments including the operating room. Most of these particles come from the surgical staff moving around in the room, positioning of the patient during surgery, and the movement…
- Trial name
- ABS (NCT01610271)
- Testing
- Air Barrier System
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Nimbic Systems, LLC
Cochlear Hearing Loss
Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation
This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound…
- Trial name
- NCT06301568
- Where
- Germany
- Volunteers
- 55 people
- Sponsor
- Advanced Bionics AG