16 completed, 2 active not recruiting, 2 approved for marketing, 2 terminated. 10 Phase 3, 4 Not applicable, 1 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 10 | Completed 8, Terminated 1, Withdrawn 1 |
| Not applicable | 4 | Active not recruiting 2, Completed 2 |
| Phase 1 | 1 | Completed 1 |
| Phase 4 | 1 | Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Memory Gel and Shape Combined Cohort MemoryShape® Breast Implants, MemoryGel® Breast Implants, Other Aesthetic Surgery - Primary Breast Augmentation, Primary Breast Reconstruction | Not applicable | Active not recruiting | Mentor Worldwide, LLC | 3603 | 2016-09-01 | 2026-09-25 |
| A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction Mentor Larger Size MemoryGel Ultra High Profile Breast Implant - Breast Reconstruction, Revision Breast Reconstruction | Not applicable | Active not recruiting | Mentor Worldwide, LLC | 400 | 2016-04-01 | 2026-09-25 |
| CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study) The Contour Profile Gel (CPG) breast implants - Breast Augmentation, Breast Reconstruction | Phase 3 | Completed | Mentor Worldwide, LLC | 1891 | 2013-08-01 | 2016-11-11 |
| Spectra Breast Implant Study Mentor Spectra/Becker 80 Breast Implant - Augmentation, Augmentation Revision | Phase 3 | Withdrawn | Mentor Worldwide, LLC | 2013-06-01 | 2013-03-01 | |
| Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty Polydioxanone (PDS) plates, Caudal septal extension graft performed through endonasal rhinoplasty - Rhinoplasty | Not applicable | Completed | DeNova Research | 30 | 2010-11-24 | 2020-11-04 |
| Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change Contour Profile Tissue Expander - Contour Irregularity of Reconstructed Breast | Not applicable | Completed | Northwestern University | 12 | 2010-11-01 | 2023-04-06 |
| Prospective Radiologic Evaluation of Changes Following Fat Grafting Breast Cancer | Completed | University of Minnesota | 35 | 2010-09-01 | 2019-11-01 | |
| A Clinical Study Evaluaing the Efficacy, Safety, and Patient Satisfaction of Injectable Hylaronic Acid With 0.3% Lidocain Hydrochloride, Prevelle Silk, for Superficial, Vertical Perioral Lines and Superficial, Horizontal, Lateral Canthal Lines Wrinkles | Unknown | Goldman, Butterwick, Fitzpatrick and Groff | 13 | 2010-08-01 | 2010-12-28 | |
| Becker Continued Access Study Mentor Becker 25 Expander/Breast Implant, Mentor Becker 50 Expander/Breast Implant - Breast Reconstruction | Phase 4 | Terminated | Mentor Worldwide, LLC | 11 | 2009-06-01 | 2019-03-06 |
| A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty Breast Augmentation, Breast Reconstruction | Completed | University of Minnesota | 142 | 2008-05-01 | 2015-02-23 | |
| A Long-Term Safety Study of Repeat Treatment With PurTox® for Frown Lines Between the Eyebrows Mentor Purified Toxin Botulinum Toxin Type A - Glabellar Rhytides | Phase 3 | Completed | Mentor Worldwide, LLC | 576 | 2008-02-01 | 2011-09-12 |
| Safety and Efficacy Study of Repeat Treatment With PurTox® Botulinum Toxin Type A for Frown Lines Between the Eyebrows Mentor Purified Toxin Botulinum Toxin Type A, Preservative-free Saline - Glabellar Rhytides, Frown Lines Between the Eyebrows | Phase 3 | Completed | Mentor Worldwide, LLC | 699 | 2007-11-01 | 2011-09-12 |
| Safety and Efficacy Study of PurTox® Botulinum Toxin Type A to Treat Frown Lines Between the Eyebrows Preservative-free Saline, Mentor Purified Toxin - Glabellar Rhytides | Phase 3 | Completed | Mentor Worldwide, LLC | 402 | 2007-06-01 | 2011-09-12 |
| A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device Dermal Gel Extra (DGE) and an FDA Approved Device for the Correction of Nasolabial Folds (NLFs) Dermal Gel Extra (DGE), Restylane, EMLA Cream - Facial Wrinkles at the Nasolabial Folds | Phase 3 | Completed | Genzyme, a Sanofi Company | 140 | 2007-05-01 | 2015-04-22 |
| Study of the Mentor Becker Expander/Breast Implant in Subjects Who Are Undergoing Primary Breast Reconstruction Mentor Smooth Becker 50 Expander/Breast Implant - Breast Reconstruction | Phase 3 | Terminated | Mentor Worldwide, LLC | 315 | 2007-03-01 | 2018-05-08 |
| Mentor MemoryGel Post-Approval Study Mentor Silicone Gel-Filled Breast Implants, Saline Breast Implants - Breast Reconstruction, Breast Augmentation | Completed | Mentor Worldwide, LLC | 42491 | 2006-11-01 | 2020-06-04 | |
| PurTox (Botulinum Toxin Type A) for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin, Physiologic saline - Spasmodic Torticollis | Phase 1 | Completed | Mentor Worldwide, LLC | 70 | 2006-05-01 | 2016-03-29 |
| PREVELLE Shape (CX002) Dermal Filler Protocol PREVELLE Shape, Restylane - Correction of Nasolabial Folds and Lip Augmentation | Phase 3 | Completed | Mentor Worldwide, LLC | 2004-10-01 | 2011-12-20 | |
| Post Approval Continued Access Study of the MENTOR® Contour Profile Gel Breast Implant Mentor Siltex® Contour Profile Gel Mammary Prosthesis - Breast Augmentation, Breast Reconstruction | Approved for marketing | Mentor Worldwide, LLC | 2004-08-01 | 2014-12-02 | ||
| Evaluating the Effectiveness and Outcomes of Silicone Breast Prosthetics Breast Cancer | Completed | University of California, Irvine | 132 | 2002-05-24 | 2023-04-27 |
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Breast Neoplasms (3) · Torticollis (1)
Breast Implants (5) · Botulinum Toxins (3) · Botulinum Toxins, Type A (3) · Sodium Chloride (2) · Bone Plates (1) · Lidocaine (1) · Lidocaine, Prilocaine Drug Combination (1) · Prilocaine (1)
United States (22) · France (1)
John Canady, M.D. (3) · Corey Maas, MD (2) · David Caplin, M.D. (2) · Dennis Hammond, M.D. (2) · Joseph Bauer, M.D. (2) · Barry Fernando, M.D. (1) · Bradley Remington, M.D. (1) · Bruce L Cunningham, MD (1) · Carolyn Austin (1) · Cayce Rumsey, M.D. (1) · Corey Maas (1) · Craig Colville, M.D. (1) · David A. Stoker, M.D. (1) · Douglas Wagner, M.D. (1)
PMID 25158767, PMID 14578788, PMID 22286418, PMID 23562485, PMID 26501937, PMID 33620918