Clinical trials: Prostheses
Amputation, Amputation, Traumatic
Evaluation of Dexterous Terminal Device
Liberating Technologies, Inc. (LTI) has developed Pointdexter, a dexterous prosthetic fingertip that is integrated into a commercial prosthetic hand and allows for an additional fine grasp.
- Conditions
- Amputation, Amputation, Traumatic, Amputation; Traumatic, Hand, Limb; Absence, Congenital, Upper
- Trial name
- NCT05840601
- Testing
- Pointdexter, Comparator
- Sponsor
- Liberating Technologies, Inc.
Complication, Prosthesis Durability
SEBBIN Silicone Gel-filled Testicular Implants
This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device.
- Trial name
- NCT04968470
- Where
- 2 sites in Belgium, France
- Volunteers
- 100 people
- Sponsor
- Groupe SEBBIN
Aortic Arch; Aneurysm, Dissecting
Study of the Thoraflex™ Hybrid Device for the Treatment of Aneurysm/Dissection of the Descending Thoracic Aorta
The purpose of this national observational study is to evaluate the Thoraflex™ Hybrid vascular prosthesis in the replacement of the aortic arch and the treatment of aneurysm/dissection of the descending thoracic aorta in relation…
- Trial name
- NCT03735472
- Testing
- Thoraflex™ Hybrid
- Where
- 37 sites in France
- Volunteers
- 351 people
- Sponsor
- Vascutek Ltd.
Femoral Vascular Anastomosis
Post-Marketing Surveillance of TISSUCOL for Hemostasis in Subjects Undergoing Vascular Reconstruction With Polytetrafluoroethylene (PTFE) Prosthesis
This study investigates if the time to hemostasis can be reduced by application of Tissucol® onto femoral vascular anastomoses with PTFE prostheses compared to standard methods, such as compression with swabs.
- Trial name
- NCT00163592
- Testing
- Tissucol®, Control: Conventional treatment, i.e. compression with swabs
- Where
- 5 sites in Austria, Germany
- Volunteers
- 60 people
- Sponsor
- Baxter Healthcare Corporation
Surgery
Prospective, Multicenter Observational Study Evaluating the Long Term Safety of the Custombone Implant
A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™ The patients will be included as soon as they…
- Trial name
- CUSTOMBONE (NCT01824706)
- Testing
- craniectomy
- Where
- 18 sites in France
- Volunteers
- 110 people
- Sponsor
- Integra LifeSciences Corporation
Osteoarthritis, Hip
Clinical Outcomes Following Total Joint Replacement With Corin Prostheses: Corin MetaFix Collared Stem
Assessment of the clinical performance and survivorship of the Corin Total Hip System with Trinity™ cup MetaFix™ Collared stem in a prospective study.
- Trial name
- NCT05121636
- Testing
- MetaFix Collared Stem
- Volunteers
- 51 people
- Sponsor
- Corin
Dental Malocclusion, Edentulous Mouth
Safety and Technical Performance of Plastalgin and Plastalgin Fast in Patients Requiring a Dental Impression
The aim of this study is to gather clinical data related to the use of Plastalgin and Plastalgin Fast, in order to comply with the new medical device regulation.
- Conditions
- Dental Malocclusion, Edentulous Mouth, Dental Misalignment
- Trial name
- NCT05614635
- Testing
- Plastalgin and Plastalgin Fast
- Where
- 2 sites in France
- Volunteers
- 59 people
- Sponsor
- Septodont
Total Laryngectomy
Long Term Use of the Provox Vega 22.5
The purpose of this study was to investigate the long-term feasibility of the new Provox Vega 22.5 voice prosthesis (outer diameter of 22.5 French) and its insertion system (SmartInserter) in laryngectomized patients who…
- Trial name
- NCT00884910
- Testing
- Provox Vega voice prosthesis 22.5 Fr
- Where
- Netherlands
- Volunteers
- 33 people
- Sponsor
- Atos Medical AB
Amputation, Amputation; Traumatic, Hand
Dexterous Partial Hand Prosthesis Outcomes
Liberating Technologies, Inc. (LTI) has developed a dexterous prosthetic fingertip that will be fit onto an i-Digits™ partial hand prosthesis and allow for an additional fine grasp.
- Conditions
- Amputation, Amputation; Traumatic, Hand, Limb; Absence, Congenital, Upper, Prosthesis User
- Trial name
- NCT05038566
- Testing
- Pointdexter
- Where
- 2 sites in United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Amputation of Upper Limb
A Multicenter, Multinational, Cohort Long-term Post-market Clinical Follow-up (PMCF) of the Safety and Efficacy of the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System When Used for Transhumeral Implantation in Amputee Patients
This non-interventional clinical investigation is initiated for the purpose of long-term Post-Market Clinical Follow-up (PMCF) and the follow-up time of patients is expected to span from 6 months to >20 years in function.
- Trial name
- ReTHro (NCT06753110)
- Testing
- OPRA transhumeral
- Where
- 6 sites in Australia, Austria and 3 more
- Volunteers
- 70 people
- Sponsor
- Integrum
Osteoarthritis of Hip, Congenital Hip Dysplasia
Clinical and Radiographic Outcomes of the Corin Tri-Fit Total Hip Replacement
The study will evaluate the radiographs (x-rays) of 100 patients with a TriFIT total hip at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery to see if there has been any movement or wear in the hip stem over…
- Conditions
- Osteoarthritis of Hip, Congenital Hip Dysplasia, Avascular Necrosis
- Trial name
- NCT02162186
- Where
- Canada
- Volunteers
- 37 people
- Sponsor
- Corin
Blepharoptosis
Custom Print Megnetic Levator Prosthesis Pilot Comparison
Study the device feasibility of non-surgical treatment for blepharoptosis (inability to open the eyelid) consisting of a biocompatible magnetic element adhered to the upper eyelid and a second magnet above the eye on a custom…
- Trial name
- NCT04807855
- Testing
- The cMLP device
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Skelmet Inc
Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses
FS VH S/D 500 S-apr in Vascular Surgery
The purpose of this study was to compare safety and efficacy of FS VH S/D 500 s-apr (FS) versus manual compression in prosthetic expanded polytetrafluoroethylene (ePTFE) graft placement.
- Trial name
- NCT00892957
- Testing
- Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), Surgical gauze pads
- Where
- 22 sites in United States
- Volunteers
- 176 people
- Sponsor
- Baxter Healthcare Corporation
Osteoarthritis
A Post-Market Retrospective Study on Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis
This is a retrospective, single-site observational study, designed to assess the clinical outcomes and collect safety data of GMK Revision knee system used for primary or revision total knee arthroplasty at minimum two years…
- Trial name
- NCT02912351
- Testing
- Patient record review, Radiographs, and questionaires.
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Medacta USA
Aneurysm Arterial, Peripheral Arterial Disease
Safety and Performance of POLYTHESE® Vascular Prosthesis
POLYTHESE® study is a retrospective, observational, multicentre, case series which examine short and long-term outcomes of using POLYTHESE®.
- Conditions
- Aneurysm Arterial, Peripheral Arterial Disease, Marfan Syndrome, Arterial Dissections
- Trial name
- NCT05516043
- Testing
- Implantation with POLYTHESE®
- Where
- 3 sites in France
- Volunteers
- 256 people
- Sponsor
- Perouse Medical
Laryngeal Cancer, Hypopharynx Cancer
A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients
This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a novel Tracheo-Esophageal voice Prosthesis for total laryngectomy +/- partial pharyngectomy patients.
- Trial name
- TEP (NCT03039465)
- Testing
- Modified Trans-Esophageal Prosthesis
- Where
- India
- Volunteers
- 50 people
- Sponsor
- HealthCare Global Enterprise Ltd.
Osteoarthritis
Five and Ten Year Results of the CMK21 Hip System
Five and ten year results of the CMK21 Hip system
- Trial name
- CMK21 (NCT03908151)
- Testing
- CMK21 Hip system
- Where
- 2 sites in Belgium
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Smith & Nephew, Inc.
Survival, Prosthesis
Prevision® PMCF Study
Monocentric, non-interventional Post-Market Clinical Follow-Up (PMCF) Study on past implantations of the Prevision® prosthesis; the survival rate of the Prevision® prosthesis shall be evaluated and compared to literature results…
- Trial name
- NCT03510065
- Testing
- Prevision®
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Aesculap AG
Non-inflammatory Degenerative Joint Disease, Osteoarthritis
28mm Ceramic-on-Ceramic Total Hip Replacement Study
This study is intended to gather medium (0-5 years) and long-term (6-10 years) information regarding the performance and safety of the commercially available Ceramax™ Ceramic on Ceramic Total Hip System.
- Conditions
- Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-traumatic Arthritis
- Trial name
- COC28 (NCT01657435)
- Testing
- Ceramax Acetabular System
- Where
- 13 sites in United States, Canada
- Volunteers
- 185 people
- Sponsor
- DePuy Orthopaedics
Full Aniridia, Partial Aniridia
Safety and Effectiveness of the CustomFlex Artificial Iris Prosthesis for the Treatment of Iris Defects
The purpose of this study is to study the long term safety and effectiveness of an artificial iris prosthesis for the treatment of iris defects.
- Trial name
- NCT01860612
- Testing
- Artificial Iris (CustomFlex)
- Where
- 13 sites in United States
- Volunteers
- 500 people
- Sponsor
- Clinical Research Consultants, Inc.