Clinical trials: Revision
Breast Augmentation, Breast Reconstruction
Sientra Post-Approval Study
This is a ten-year postapproval study to evaluate the long-term clinical performance of Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket environment.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT01639053
- Where
- United States
- Volunteers
- 5,498 people, healthy volunteers welcome
- Sponsor
- Tiger Biosciences, LLC.
Joint Disease
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator HA Coated Modular Femoral Stems
MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (EU).
- Trial name
- NCT02314611
- Testing
- PROFEMUR® Gladiator HA Coated Modular Femoral Stem
- Where
- Belgium
- Volunteers
- 154 people
- Sponsor
- MicroPort Orthopedics Inc.
Obesity, Morbid
Early Feasibility Study: Assessment of Self-Forming Magnetic Anastomosis Device and Delivery System (SFM) in Obese Patients, When Used to Create a Duodenal-Ileal Anastomosis Post SG (SNAP-PS), or Used to Create a Jejuno-Jejunal (J-J) Anastomosis
The objectives of this study are to assess the initial safety and device functionality of the SFM Anastomosis System including delivery systems when used to create a duodenal-ileal (D-I) anastomosis with patients with prior…
- Trial name
- GIW-J-J (NCT06200896)
- Testing
- Self Forming Magnets used to Create A Compression Anastomosis
- Where
- Chile
- Volunteers
- 28 people
- Sponsor
- GI Windows, Inc.
Augmentation, Augmentation Revision
Spectra Breast Implant Study
The purpose of this study is to demonstrate safety and effectiveness of Mentor's Spectra/Becker 80 Adjustable Breast Implants in women who are undergoing primary or revision breast augmentation.
- Conditions
- Augmentation, Augmentation Revision, General Breast Enlargement, Post-lactational Involution
- Trial name
- NCT00981266
- Testing
- Mentor Spectra/Becker 80 Breast Implant
- Where
- United States
- Sponsor
- Mentor Worldwide, LLC
Joint Disease
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems
MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU.
- Trial name
- NCT02314702
- Testing
- PROFEMUR® L Revision Femoral Stem
- Where
- United Kingdom
- Volunteers
- 26 people
- Sponsor
- MicroPort Orthopedics Inc.
Osteolysis, Arthroplasty Complications
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.
- Conditions
- Osteolysis, Arthroplasty Complications, Instability of Prosthetic Joint, Degenerative Osteoarthritis
- Trial name
- NCT04255966
- Testing
- Plasmafit® Revision Structan®
- Where
- 4 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG
Osteoarthritis
The Press Fit Condylar (P.F.C.) Sigma Rotating Platform (RP) TC3 Revision Knee in Revision Knee Arthroplasty
The purpose of this study is to evaluate the long-term clinical and functional performance of the P.F.C. Sigma Rotating Platform TC3 knee system in revision knee surgery and to determine whether the implant design results in a…
- Trial name
- TC3 (NCT00733681)
- Testing
- PFC Sigma RP TC3 Revision knee system
- Where
- 9 sites in France, Germany and 2 more
- Volunteers
- 181 people
- Sponsor
- DePuy International
Breast Augmentation, Breast Reconstruction
CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study)
The CPG Styles Study is designed to demonstrate the safety of different styles of Mentor's Contour Profile Gel (CPG) breast implants in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT01959880
- Testing
- The Contour Profile Gel (CPG) breast implants
- Where
- United States
- Volunteers
- 1,891 people, healthy volunteers welcome
- Sponsor
- Mentor Worldwide, LLC
Arthroplasties, Hip Replacement
REDAPT Retrospective-Prospective Modular Stem Study
A Retrospective-Prospective Study of REDAPT Revision Femoral System Modular Stem is a post-market, retrospective-prospective, multi-center, single arm, consecutive series study design to provide data on the post market…
- Trial name
- NCT02661620
- Testing
- REDAPT Revision Femoral System modular stem
- Where
- 5 sites in United States, Belgium and 1 more
- Volunteers
- 140 people
- Sponsor
- Smith & Nephew, Inc.
Hip Arthropathy
Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems
This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF.
- Trial name
- 2022-10 (NCT06096168)
- Where
- France
- Volunteers
- 42 people
- Sponsor
- Societe dEtude, de Recherche et de Fabrication
Keloid
A Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults
To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision.
- Trial name
- NCT02079168
- Testing
- RXI-109
- Where
- 3 sites in United States, Dominican Republic
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- RXi Pharmaceuticals, Corp.
Breast Augmentation, Breast Reconstruction
NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study
Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- Trial name
- NCT01853605
- Testing
- Anatomically shaped silicone gel-filled breast implants
- Where
- United States
- Volunteers
- 3,811 people, healthy volunteers welcome
- Sponsor
- Allergan
Atrial Fibrillation Recurrent
Redo AF Sub Study (of the Pure EP 2.0 Main Study)
This study is a sub study of the Pure EP 2.0 trial. In a redo atrial fibrillation population, this study is designed to collect pulmonary vein signals pre and post ablation therapy, along with other non-pulmonary vein signals of…
- Trial name
- NCT04964440
- Testing
- Pure-EP
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- BioSig Technologies, Inc.
Bone Necrosis, Arthritis/Arthrosis
Prospective Clinical 5-year Follow-up of the LINK® Endo-Model® SL®
The objective of this study is to collect outcome information on patients requiring Total Knee Replacement (TKR) in primary or revision cases and therefore receiving the LINK® Endo-Model® SL® under routine conditions.
- Conditions
- Bone Necrosis, Arthritis/Arthrosis, Failure of Prosthetic Joint Implant
- Trial name
- NCT02367417
- Where
- 3 sites in Germany
- Volunteers
- 61 people
- Sponsor
- Waldemar Link GmbH & Co. KG
Breast Augmentation, Breast Reconstruction
Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study
Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT00905645
- Testing
- Silimed Gel-Filled Mammary Implant
- Where
- United States
- Volunteers
- 1,788 people
- Sponsor
- Tiger Biosciences, LLC.
Common Iliac Artery Aneurysm, Aorto Iliac Aneurysm
Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac Revascularization
The IBE 25-05 study will be a prospective, non-randomized, multicenter, interventional two arm evaluation designed to assess the safety and effectiveness of the GORE® EXCLUDER® IBE Plus Stent Graft in patients with common iliac…
- Trial name
- NCT07304102
- Testing
- GORE® EXCLUDER® IBE Plus Stent Graft
- Volunteers
- 100 people
- Sponsor
- W.L.Gore & Associates