Clinical trials: Revision
Renal Failure, Hemodialysis
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the…
- Trial name
- REVISE (NCT00737672)
- Testing
- GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface, Percutaneous Transluminal Angioplasty
- Where
- 31 sites in United States
- Volunteers
- 293 people
- Sponsor
- W.L.Gore & Associates
Reduction in Hypertrophic Skin Scarring
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing revision of scars from prior surgery.
- Trial name
- NCT01346969
- Testing
- EXC 001
- Where
- 12 sites in United States
- Volunteers
- 68 people
- Sponsor
- Pfizer
Subjects Requiring Revision Breast Augmentation Surgery
SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery
An evaluation of the clinical performance of SERI® Surgical Scaffold for soft tissue support in subjects undergoing revision augmentation surgery for increased nipple to inframammary fold distance.
- Trial name
- NCT02030938
- Testing
- SERI® Surgical Scaffold
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Sofregen Medical, Inc.
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants
This is a prospective, multicenter study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Style and L-Style Breast Implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- Trial name
- NCT01785069
- Testing
- Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
- Where
- 29 sites in United States
- Volunteers
- 355 people, healthy volunteers welcome
- Sponsor
- Allergan
Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery
A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study
Study is a multicenter, two-part, open-label phase II study in adults, evaluating the safety and long-term efficacy of PF-06473871 one year after surgical revision and treatment with PF-06473871.
- Trial name
- NCT02205476
- Testing
- PF-06473871
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Pfizer
Breast Reconstruction, Breast Augmentation
Mentor MemoryGel Post-Approval Study
In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional…
- Conditions
- Breast Reconstruction, Breast Augmentation, Breast Revision
- Trial name
- MGPAS (NCT00756652)
- Testing
- Mentor Silicone Gel-Filled Breast Implants, Saline Breast Implants
- Volunteers
- 42,491 people, healthy volunteers welcome
- Sponsor
- Mentor Worldwide, LLC
Osteoarthritis, Degenerative Arthritis
PINNACLE® DM RSA Study
The primary objective is to establish the mean superior cup migration of the PINNACLE® Dual Mobility Construct using model-based RSA over the first two years post-implantation.
- Conditions
- Osteoarthritis, Degenerative Arthritis, Revision Arthroplasty
- Trial name
- PIN DM (NCT05357664)
- Testing
- Total Hip Arthroplasty, Revision Total Hip Arthroplasty
- Where
- 3 sites in Canada
- Volunteers
- 11 people
- Sponsor
- DePuy Orthopaedics
Hearing Loss
Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy
The Sponsor values the progression of hearing healthcare practice and acknowledges a need for re-evaluation of indications for determining adult cochlear implant candidacy.
- Trial name
- NCT01337076
- Testing
- cochlear implant
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Cochlear
Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos
Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup
The purpose of this study is to demonstrate the performance and reliability of Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.
- Conditions
- Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos, Femur Head Necrosis, Femur Neck Fracture
- Trial name
- NCT02062450
- Testing
- Primary surgery with Dual Mobility Cup, Revision surgery with Dual Mobility Cup
- Volunteers
- 379 people
- Sponsor
- Stryker Trauma and Extremities
Myelodysplastic Syndrome, Myelodysplastic Syndromes
Safety, Clinical Activity, Pharmacokinetics (PK) and Pharmacodynamics Study of GSK2879552, Alone or With Azacitidine, in Subjects With High Risk Myelodysplastic Syndromes (MDS)
This is a Phase I/II, open-label, 2 arm study to evaluate the safety and clinical activity of GSK2879552 alone, or in combination with azacitidine in subjects with MDS. The study consisted of 2 parts.
- Trial name
- NCT02929498
- Testing
- GSK2879552, Azacitidine
- Where
- 6 sites in United States, Spain
- Volunteers
- 7 people
- Sponsor
- GlaxoSmithKline
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
Arthroplasty, Hip Revision
Trident II Revision Outcomes Study
The purpose of this study is to review the performance and success rate of an FDA cleared cementless hip replacement part called the Trident II Tritanium Acetabular Shell.
- Trial name
- NCT04317586
- Testing
- Trident II Tritanium Acetabular Shell for Revision
- Where
- 10 sites in United States
- Volunteers
- 17 people
- Sponsor
- Stryker Orthopaedics
Breast Reconstruction
Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.
- Trial name
- NCT00691327
- Testing
- Natrelle(TM) Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 84,329 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Scar Prevention
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
This study will compare how well EXC 001 works to improve the appearance of scars in subjects undergoing breast scar revision surgery. The study will also evaluate the safety of EXC 001 in healthy adult subjects.
- Trial name
- NCT01037413
- Testing
- EXC 001
- Where
- 5 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
Arthroplasty, Replacement, Hip
Trident® Tritanium™ Acetabular Shell Revision Study
The purpose of this study is to evaluate a hip implant system used when a previous hip replacement surgery has failed.
- Trial name
- NCT00535626
- Testing
- Trident® Tritanium™ Acetabular Shell
- Where
- 15 sites in United States
- Volunteers
- 241 people
- Sponsor
- Stryker Orthopaedics
Myelodysplastic Syndromes (MDS)
A Phase 1b/2 Study of Alvocidib Plus Decitabine or Azacitidine in Patients With MDS
Alvocidib, a cyclin-dependent kinase 9 (CDK 9) inhibitor, in time-sequential therapy demonstrated significant clinical activity in secondary AML patients with prior MDS.
- Trial name
- NCT03593915
- Testing
- Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine
- Where
- 12 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sumitomo Pharma America, Inc.
Obstructive Sleep Apnea
Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP)
The purpose of this protocol is to improve the current FDA-approved continuous positive pressure auto-titration algorithm, including treatment precision, residual disease detection characteristics and phenotyping with the…
- Trial name
- NCT01797705
- Testing
- DeVilbiss AutoAdjust CPAP with revised algorithm
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- DeVilbiss Healthcare LLC
Atrial Septal Defect, Ventricular Septal Defect
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery.
- Conditions
- Atrial Septal Defect, Ventricular Septal Defect, Atrioventricular Septal Defect
- Trial name
- NCT01120964
- Testing
- Intravenous L-Citrulline
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Reduction of Hypertrophic Skin Scarring
Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery
The study will compare how well PF-06473871 works versus placebo in reducing skin scarring after scar revision surgery of existing breast scars. The study will also evaluate the safety of PF-06473871 in healthy adult subjects.
- Trial name
- NCT01730339
- Testing
- PF-06473871
- Where
- 40 sites in United States, Germany and 2 more
- Volunteers
- 103 people
- Sponsor
- Pfizer
Reduction in Severity of Skin Scarring
Safety and Efficacy of EXC 001 in Subjects Who Have Participated in Prior Studies of EXC 001
The purpose of this study is to provide subjects who participated in prior studies of EXC 001 the opportunity to have their hypertrophic scars surgically revised and treated with EXC 001.
- Trial name
- NCT01494922
- Testing
- EXC 001 (currently called PF-06473871)
- Where
- 4 sites in United States
- Volunteers
- 14 people
- Sponsor
- Pfizer