Clinical trials: Implants, open to volunteers
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
- 4 sites in Austria, Germany
- Volunteers
- 100 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Hearing Loss, Hearing Implants
A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults
The aim of this clinical investigation is to demonstrate the performance, clinical benefit and safety of commercial cochlear implant systems.
- Trial name
- ORBIT-MU (NCT07338864)
- Testing
- Cochlear Nucleus Nexa Cochlear implant (CI1032), Cochlear Nucleus Nexa Cochlear implant (CI1022), Cochlear Nucleus Nexa Cochlear implant (CI1012)
- Where
- Germany
- Volunteers
- 66 people
- Sponsor
- Cochlear
Dental Implant
Assessing Current Clinical Concepts in Dental Practice
This purpose of this database is to collect, store and use appropriately derived data from routine patient care in a specialist dental practice.
- Trial name
- NCT03003052
- Testing
- Dental implants
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- The Campbell Clinic, UK
Peri-implantitis, Peri-implant Bone Loss
Access to Probing and Peri-implant Diseases
This multicenter cross-sectional study aims to evaluate the association between access to peri-implant probing and radiographic peri-implant bone loss.
- Trial name
- NCT07557459
- Testing
- Peri-implant probing
- Where
- 9 sites in Spain
- Volunteers
- 281 people
- Sponsor
- Arrow Development
Breast Implant Revision
LTFU of PCL Breast Scaffolds Used in 2021-BRV-004
The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with…
- Trial name
- NCT07383012
- Where
- Australia
- Volunteers
- 19 people
- Sponsor
- BellaSeno Pty Ltd
Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III
Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
Prospective, randomized, controlled study to assess the safety and effectiveness of GalaFLEX LITE™ Scaffold in revision surgery for reduction of capsular contracture recurrence and/or malposition in implant-based breast…
- Conditions
- Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III, Capsular Contracture Grade IV
- Trial name
- STANCE (NCT05945329)
- Testing
- GalaFLEX LITE™ Scaffold, Standard surgery
- Where
- 37 sites in United States
- Volunteers
- 250 people
- Sponsor
- C. R. Bard
Cochlear Implants
Middle East MED-EL Observatory Study
In the field of cochlear implant research, there are only few data on long-term observational studies available to gain knowledge on clinical effectiveness.
- Trial name
- MEMOS (NCT03882229)
- Testing
- MED-EL CI systems
- Where
- 3 sites in Egypt, Saudi Arabia
- Volunteers
- 100 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Breast Implant Rupture
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Rupture
This prospective dynamic cohort will follow women with intact aesthetic silicone breast implants to evaluate predictors of rupture.
- Trial name
- NCT07810205
- Testing
- Silicone Breast Implant Exposure, Prospective Breast Implant Surveillance Imaging
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Capsular Contracture of Breast Implant
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture
This prospective breast implant surveillance cohort will evaluate whether implant age, pocket plane, incision route, surface texture, and volume predict clinically significant capsular contracture.
- Trial name
- NCT07810231
- Testing
- Breast Implant Exposure, Standardized Capsular Contracture Assessment
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Breast Implant Complication, Breast Implant Shell Defect
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Shell Fissure
This prospective implant-surveillance cohort will evaluate predictors of breast implant shell fissure. Women with aesthetic implants without baseline fissure or rupture will undergo annual clinical and imaging assessment for up…
- Trial name
- NCT07810257
- Testing
- Breast Implant Exposure, Structured Implant Shell Imaging
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Breast Implant Malposition, Breast Implant Rotation
Prospective Two-Year Cohort Study of Surgical and Implant Predictors of Breast Implant Displacement and Rotation After Aesthetic Augmentation
This prospective inception cohort will follow women for ten years after primary or revision aesthetic breast implantation. Pocket plane, incision route, implant texture, shape, volume, and operative pocket variables will be…
- Trial name
- NCT07810270
- Testing
- Aesthetic Breast Implantation, Standardized Implant Position Assessment
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Systemic Symptoms, Breast Implant Illness
Prospective Controlled Cohort Study of the Incidence, Trajectory, and Clinical Correlates of Persistent Systemic Symptoms in Women With and Without Silicone Breast Implants
This prospective controlled cohort will enroll women before primary aesthetic breast surgery. Women receiving silicone implants will be compared with women undergoing nonimplant mastopexy or reduction.
- Conditions
- Systemic Symptoms, Breast Implant Illness, Breast Implant Complications
- Trial name
- NCT07810803
- Testing
- Silicone Breast Implant Exposure, Standardized Systemic Symptom and Psychosocial Assessment
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Cochlear Implant Users
Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso 3 Sound Processors by Experienced Cochlear Implant Users
This study aims to investigate acceptance and performance of the Bluetooth Low Energy Audio-enabled (LE Audio) firmware in the Nucleus 8 Processing Unit, Kanso 3 Nexa Sound Processor, and the Kanso 3 Sound Processor.
- Trial name
- STREAM (NCT07262827)
- Testing
- Nucleus 8 Sound Processor streaming via MultiMic+, Nucleus 8 Sound Processor microphones, Nucleus 8 Sound Processor streaming via Roger 20
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- Cochlear
Atrial Fibrillation, Oral Anticoagulation
Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation
Patients with atrial fibrillation (AF) who have had a prior stroke are at very high risk of recurrent ischemic stroke. About 40% of these strokes are due to large emboli which result in large cerebral vessel occlusion (LVO).
- Conditions
- Atrial Fibrillation, Oral Anticoagulation, Stroke, Implant
- Trial name
- INTERCEPT (NCT05723926)
- Testing
- Vine Filter
- Where
- 21 sites in United States, Brazil and 2 more
- Volunteers
- 2,000 people
- Sponsor
- Javelin Medical
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, 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)