Clinical trials: Implant
Congenital Hearing Loss, Bilateral Cochlear Implants
Investigating the Neural Oscillatory Features for Limited Access to Oral Language in Deaf Children With Early Bilateral Cochlear Implantation
Children with severe-to-profound congenital hearing loss often experience significant language development challenges. While cochlear implants (CIs) can restore auditory input, outcomes vary widely, even among those who receive…
- Trial name
- ICO (NCT07739433)
- Volunteers
- 150 people
- Sponsor
- Institut Pasteur
Peri Implant Mucositis, Peri Implantitis
Study on the Treatment of Dental Implants Using the AmbiJet System for Peri-implantitis and Peri-implant Mucositis
Inflammation of the tissue surrounding a dental implant (peri-implantitis or peri-implant mucositis) can lead to implant loss in advanced stages.
- Trial name
- AmbiJet-FIH (NCT07722715)
- Testing
- AmbiJet cold plasma system, Standard Mechanical Debridement (S3 Guideline)
- Where
- Ukraine
- Volunteers
- 26 people
- Sponsor
- Freiburger Medizintechnik GmbH
Cochlear Implants, Cochlear Implantation
Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are: 1.
- Conditions
- Cochlear Implants, Cochlear Implantation, Hearing Loss
- Trial name
- NCT06375278
- Testing
- Intra-Ear Canal Cooling Catheter
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Restorear Devices LLC
Breast Implant
Motiva Implants® Post-Approval Study
This study examines the general post-market use and safety of Motiva Implants® and gathers and assesses selected safety and effectiveness data about their post market performance and experience.
- Trial name
- Motiva PAS (NCT06938399)
- Testing
- Silicone gel-filled breast implants - Motiva Implants®, Aesthetic Surgery
- Where
- 33 sites in United States
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- Motiva USA LLC
Breast Implant Revision, Congenital Breast Defect Correction
Scaffold-guided Breast Surgery
The clinical trial is testing the use of a novel method to grow new tissue within the breast injecting fat tissue harvested from patient's own fat deposits.
- Trial name
- NCT05437757
- Testing
- Surgical implantation of the PCL Breast scaffold with autologous fat grafting
- Where
- Australia
- Volunteers
- 19 people
- Sponsor
- BellaSeno Pty Ltd
Breast Implant Revision, Breast Augmentation Complications
Scaffold-guided Breast Implant Revision and Primary Breast Augmentation Surgery
The objective of the clinical investigation is to demonstrate safety and clinical performance of the absorbable polycaprolactone (PCL) breast scaffold combined with autologous fat grafting (AFG) for primary breast augmentation…
- Conditions
- Breast Implant Revision, Breast Augmentation Complications, Primary Breast Augmentation Surgery
- Trial name
- NCT07367698
- Testing
- Implantation of the PCL Breast scaffold with autologous fat grafting
- Where
- 3 sites in Australia
- Volunteers
- 87 people
- Sponsor
- BellaSeno Pty Ltd
Breast Augmentation, Breast Reconstruction
A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants
The goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical…
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision-Augmentation, Breast Reconstruction With Silicone Implants
- Trial name
- NCT07679594
- Testing
- Breast augmentation surgery, Breast reconstruction surgery
- Where
- 2 sites in France, Spain
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- GCA (Eurosilicone)
Breast Reconstruction, Breast Reconstruction Following Mastectomy
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive being the primary indications. In order to confidently state safety and due to strict regulation on medical devices it is important to…
- Conditions
- Breast Reconstruction, Breast Reconstruction Following Mastectomy, Breast Revision, Breast Augmentation
- Trial name
- PERLE10PMCF (NCT06013514)
- Testing
- PERLE Sterile Smooth Opaque gel filled mammary implants
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- GCA (Eurosilicone)
Cochlear Implant Users
This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Cochlear Implant Recipients.
Cochlear implants help individuals with hearing loss by delivering electrical signals directly to the auditory nerve, bypassing damaged parts of the ear.
- Trial name
- M11S3 (NCT07213505)
- Testing
- Testing new front-end features
- Where
- 2 sites in Austria
- Volunteers
- 40 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance
Safety and Performance of Motiva® Sizers
The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.
- Conditions
- Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance, Mammaplasty, Breast Reconstruction
- Trial name
- NCT06274736
- Testing
- Motiva Sizer
- Where
- Costa Rica
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Establishment Labs
Cochlear Implant, Hearing Loss, Bilateral or Unilateral
The Performance of Different Sound Paths in Adult NeuroZti CI-users
The goal of this clinical trial is to compare speech perception and user satisfaction between two sound paths, Nuc8 (Cochlear Nucleus sound path) and Neu2 (Neuro 2 sound path), in adult users of the NeuroZti cochlear implant.
- Trial name
- Percepolis (NCT07033130)
- Testing
- OMRP R2 + Percepolis Accessory Software, Nuc8 Sound Path, Neu2 Sound Path
- Where
- France
- Volunteers
- 4 people
- Sponsor
- Cochlear
Prosthesis and Implants
Transdermal Compress IDE Study
The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations.
- Trial name
- NCT06134167
- Testing
- Transdermal Compress Device
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Balmoral Medical company
Prostate Cancer, Prostate Cancer Patients With Detectable PSA Following Prostatectomy
64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer
The aim for this study is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
- Conditions
- Prostate Cancer, Prostate Cancer Patients With Detectable PSA Following Prostatectomy, Prostate Cancer Recurrent, Prostate Cancer Patients Who Have Brachytherapy Seed Implant
- Trial name
- AMPLIFY (NCT06970847)
- Testing
- 64Cu-SAR-bisPSMA
- Where
- 22 sites in United States, Australia
- Volunteers
- 220 people
- Sponsor
- Clarity Pharmaceuticals Ltd
Dental Implants, Single-Tooth
Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT.
A post-market, multi-centre, prospective, open, randomized-controlled, non-inferiority clinical study to compare short-term performance and safety of the Straumann PURE 2-piece Ceramic Implant with Straumann Bone Level Implant…
- Trial name
- NCT03908177
- Testing
- Ceramic Dental Implant, Titanium Dental Implant
- Where
- 3 sites in Germany, Hong Kong and 1 more
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Institut Straumann AG
Partially Edentulous Jaw, Tooth Loss
Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon
The Falcon Study is a prospective, multicenter, multinational clinical investigation evaluating the Straumann® Dynamic Navigation System (Falcon) for dental implant placement.
- Conditions
- Partially Edentulous Jaw, Tooth Loss, Dental Implant
- Trial name
- Falcon (NCT07518615)
- Testing
- Post-operative Cone Beam Computed Tomography (CBCT), Straumann Falcon Dynamic Navigation System, Dental Implants
- Where
- 4 sites in Belgium, Italy and 2 more
- Volunteers
- 75 people
- Sponsor
- Institut Straumann AG
Wisdom Teeth, Wisdom Teeth Extraction or Jaw Implant
NeuroCuple to Mitigate Post-Wisdom Teeth Extraction Opioid Risks
This is a randomized (1:1), placebo-controlled clinical trial that will examine the feasibility and effectiveness of a 2-day application of the NeuroCuple device for pain relief and reduction of opioid use following wisdom teeth…
- Trial name
- NCT07461506
- Testing
- NEUROCUPLE™ Patch
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- nCap Medical
Penile Implant
A Study on the Safety and Effectiveness of Subcutaneous Silicone Penile Implant Surgery
This study will identify a patient population who wishes to address a variety of concerns about the size, shape, or appearance of their penis with the placement of a subcutaneous Silicone Block Penile Implant.
- Trial name
- NCT04985123
- Testing
- Pre-Formed Penile Silicone Block Implant
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- International Medical Devices, Inc.
Hearing Loss, Unilateral, Cochlear Implants
Impact of Anatomy-Based Cochlear Implant Programming on Early Performance
The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users using electric-only stimulation in the implanted ear with normal hearing to…
- Conditions
- Hearing Loss, Unilateral, Cochlear Implants, Hearing Loss, Sensorineural, Single-Sided Deafness (SSD)
- Trial name
- NCT06734039
- Testing
- Programming of cochlear implant audio processor frequency settings
- Where
- 6 sites in United States
- Volunteers
- 50 people
- Sponsor
- Med-El Corporation
Pelvic Organ Prolapse (POP), Synthetic Mesh
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
The purpose of this clinical investigation is to collect clinical data about the ProGYNious Mesh based on a prospective clinical investigation.
- Conditions
- Pelvic Organ Prolapse (POP), Synthetic Mesh, Laparoscopic Surgery, Gynecologic Laparoscopic Surgery
- Trial name
- ProGYNious (NCT07497321)
- Testing
- Surgical mesh for pelvic organ prolapse repair (ProGYNious)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 100 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Breast Implant; Complications, Quality of Life
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants
The study investigates the safety and performance of Silimed® silicone gel breast implants with a textured surface and Silimed® silicone gel breast implants with polyurethane coated surface.
- Conditions
- Breast Implant; Complications, Quality of Life, Satisfaction
- Trial name
- STEPS A (NCT03356132)
- Testing
- Silimed® Textured Silicone Gel-Filled Breast Implant, Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant
- Where
- Brazil
- Volunteers
- 632 people, healthy volunteers welcome
- Sponsor
- Silimed Industria de Implantes Ltda