Clinical trials: IMPLANTATION, open to volunteers
Vertebral Compression Fracture
A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression Fractures
This study is being conducted to evaluate the safety and performance of the VCFix Spinal System, a medical device designed to treat certain types of spinal fractures called vertebral compression fractures (VCFs) in adults.
- Trial name
- EXPAND (NCT07301749)
- Testing
- VCFix Spinal System in stand-alone configuration
- Where
- 3 sites in France, Germany
- Volunteers
- 148 people
- Sponsor
- Amber Implants B.V.
Glaucoma
Phase 2 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
- Trial name
- NCT07075718
- Testing
- Gen 2 Travoprost Intracameral Implant, Timolol eye drops 0.5%
- Where
- 3 sites in United States
- Volunteers
- 110 people
- Sponsor
- Glaukos Corporation
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
Cochlear Hearing Loss
MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE
The goal of this interventional study is to describe how people with cochlear implants perceive the perceive speech in noise and their sound environment on adults who are native French speakers with typical hearing or with…
- Trial name
- MIRACLE (NCT06420921)
- Testing
- Speech in noise comprehension test, Objective tests of perception of ambient sound cues in noise, Subjective tests of perception of ambient sound cues in noise
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Gonarthritis, Degenerative Disease
Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Implant
The study is designed as a prospective, observational, mid-term, multi-center follow-up study. It is planned to include 150 patients from 4 different study centres in Germany.
- Trial name
- UNI_XF_PRO (NCT06657248)
- Testing
- univation® XF Pro
- Where
- 4 sites in Germany
- Volunteers
- 150 people
- Sponsor
- Aesculap AG
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)
Edentulism, Tooth Loss
5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece.
The goal of this cohort observational study is to compare in the survival rate of ceramic dental implants placed in patients with missing or hopeless teeth .
- Trial name
- 240101 (NCT06287346)
- Testing
- dental implant
- Where
- 2 sites in United States, Spain
- Volunteers
- 652 people
- Sponsor
- CeraRoot SL
Heart Failure, Systolic Bundle Branch Block, Left
Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator…
- Trial name
- ACHIEVED LBBAP (NCT07526896)
- Testing
- LBBAP Therapy, LOT-CRT, ICD
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Stenosis
FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis
The main objective of this study is to evaluate the feasibility and safety of the GEMINUS system in patients with severe symptomatic aortic stenosis.
- Trial name
- NCT05909748
- Testing
- GEMINUS Transcatheter Aortic Valve Implantation system
- Where
- 2 sites in Israel
- Volunteers
- 30 people
- Sponsor
- Valve Medical
Cochlear Implantation, Sensorineural Hearing Loss
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
MED-EL Cochlear Implants (CI) provide auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing-impaired individuals who obtain little or no benefit from acoustic amplification in…
- Trial name
- LORIS (NCT07697911)
- Testing
- Transfer of data of SONATA 2 cochlear implant recipients
- Where
- 2 sites in Spain
- Volunteers
- 200 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Bilateral Hearing Loss
Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
- Trial name
- CI-DEX-LTFU (NCT06936449)
- Testing
- CI632D, CI632
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Cochlear
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
Prosthetic-joint Infection
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
The goal of this clinical trial is to evaluate whether the investigational drug PLG0206 can help reduce recurrence of infection in adults who have undergone total knee replacement and are receiving a DAIR (Debridement…
- Trial name
- RETAIN (NCT07214311)
- Testing
- PLG0206
- Where
- 21 sites in United States, United Kingdom
- Volunteers
- 240 people
- Sponsor
- Peptilogics
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
Primary Open Angle Glaucoma
A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma
Glaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab interno (inside the eye) and ab…
- Trial name
- NCT06822738
- Testing
- XEN63 Glaucoma Treatment System
- Where
- 29 sites in United States
- Volunteers
- 130 people
- Sponsor
- AbbVie
Glioma, High-Grade Glioma (HGG)
Feasibility Assessment of a Medical Device for Tumour Cell Retention and Radiotherapy Sensitization in Patients With Suspected High-grade Glioma
This is a prospective, multicenter, single-arm, pilot clinical investigation, aimed at evaluating the safety and preliminary efficacy of the GlioHook implant in patients with high-grade glioma undergoing surgical resection…
- Conditions
- Glioma, High-Grade Glioma (HGG), Surgical Resection
- Trial name
- CT-GlioHook (NCT07725640)
- Testing
- GlioHook device
- Where
- 3 sites in Spain
- Volunteers
- 15 people
- Sponsor
- Batea Oncology
Aortic Valve Stenosis
First-in-Human (FIH) Study on the Feasibility and Safety of the TaviPilot Augmented Reality Guidance Software
The trial aims to evaluate the feasibility and safety of Caranx Medical TAVIPILOT augmented reality guidance software during Transcatheter Aortic Valve Replacement Procedures.
- Trial name
- NCT07043075
- Testing
- TAVR using a guidance software
- Volunteers
- 10 people
- Sponsor
- Caranx Medical
Midface Volume Deficit
Safety and Effectiveness of Mosaic for the Treatment of Midface Volume Deficit
The goal of this clinical trial is to study whether the Mosaic Injectable Dermal Implant is a safe and effective treatment for age-related midface volume deficit in adults who are at least 22 years of age.
- Trial name
- PRIME (NCT07710443)
- Testing
- Injectable dermal implant
- Where
- 5 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Helios Aesthetics Inc.
Heart Failure
A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT.
- Trial name
- TLC-AU (NCT06561932)
- Testing
- WiSE CRT System
- Where
- 4 sites in Australia
- Volunteers
- 40 people
- Sponsor
- EBR Systems, Inc.
Aortic Stenosis, Aortic Stenosis, Severe
PARTNER 3 Trial - Aortic Valve-in-Valve
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
- Trial name
- NCT03003299
- Testing
- Edwards SAPIEN 3/SAPIEN 3 Ultra THV
- Where
- 51 sites in United States, Canada
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences