5 completed, 2 recruiting, 2 unknown, 1 terminated. 6 Not applicable, 1 Phase 1, 1 Phase 3, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 6 | Completed 4, Terminated 1, Unknown 1 |
| Phase 1 | 1 | Completed 1 |
| Phase 3 | 1 | Unknown 1 |
| Phase 4 | 1 | Recruiting 1 |
Follow Tissue Expansion Devices: new trials by email Literature Review of Tissue Expansion Devices trials Research Report on Tissue Expansion Devices
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 |
|---|---|---|---|---|---|---|
| A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement Tissue Expander (TE), Vancomycin and Gentamicin, Stimulan Rapid Cure - Breast Cancer | Phase 4 | Recruiting | Memorial Sloan Kettering Cancer Center | 392 | 2025-10-21 | 2026-07-10 |
| Post-marketing Clinical Monitoring of Safety and Performance of Breast Tissue Expander for Breast Reconstruction Breast tissue expander - Safety and Performance, Breast Tissue Expander | Recruiting | Silimed Industria de Implantes Ltda | 152 | 2025-08-06 | 2026-03-13 | |
| Pulsed Lavage in Implant-Based Breast Reconstruction Pulsed Lavage Washout, Implant-based breast reconstruction, Bilateral or unilateral mastectomy - Breast Reconstruction | Not applicable | Terminated | University of Alabama at Birmingham | 36 | 2024-03-01 | 2026-10-20 |
| Three-dimensional CBCT Analysis of Root Volume Changes Following Tooth-bone and Bone-borne Maxillary Expansion: A Pilot Study. Miniscrew insertion, Expander, CBCT - Root Resorption, Orthodontic Appliance | Not applicable | Completed | University of Roma La Sapienza | 21 | 2023-03-01 | 2025-04-04 |
| Motiva Flora Tissue Expander PMCF Breast Tissue Expander - Breast Tissue Accessory, Breast Cancer | Not applicable | Unknown | Establishment Labs | 136 | 2020-12-14 | 2024-08-27 |
| Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy Normal saline, Cefazolin, Skin biopsy - Breast Implant Infection, Mammoplasty | Phase 1 | Completed | Washington University School of Medicine | 19 | 2017-07-25 | 2019-02-08 |
| Pre-pectoral Breast Reconstruction PART 2 Two-stage with Acellular Dermal Matrix (CELLIS® Breast), Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra) - Breast Cancer | Phase 3 | Unknown | Guy's and St Thomas' NHS Foundation Trust | 86 | 2017-01-01 | 2016-10-03 |
| Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment Reconstruction with ADM., Skin or nipple sparing mastectomy, Reconstruction with implant - Breast Cancer | Not applicable | Completed | Karolinska University Hospital | 135 | 2014-04-01 | 2018-04-24 |
| Patient Controlled Tissue Expansion for Breast Reconstruction AeroForm Tissue Expansion, Saline Tissue Expansion - Breast Cancer | Not applicable | Completed | AirXpanders, Inc. | 158 | 2011-10-01 | 2017-06-27 |
| Cosmetic Result/Toxicity in Post-Mastectomy Immediate Reconstruction Expander+RT post-mastectomy radiation therapy (PMRT), tissue expander (TE), acellular dermal matrix (ADM) - Breast Cancer | Not applicable | Completed | Dana-Farber Cancer Institute | 32 | 2009-09-01 | 2019-08-26 |
Breast Neoplasms (6) · Root Resorption (1)
AirXpanders, Inc. (1) · Dana-Farber Cancer Institute (1) · Establishment Labs (1) · Guy's and St Thomas' NHS Foundation Trust (1) · Karolinska University Hospital (1) · Memorial Sloan Kettering Cancer Center (1) · Silimed Industria de Implantes Ltda (1) · University of Alabama at Birmingham (1) · University of Roma La Sapienza (1) · Washington University School of Medicine (1)
United States (5) · United Kingdom (2) · Brazil (1) · Chile (1) · Costa Rica (1) · Italy (1) · Panama (1) · Spain (1) · Sweden (1)
Danielle Rochlin, MD (1) · Fredrik Lohmander, MD (1) · Jeffrey A. Ascherman, M.D. (1) · Julia Wong, MD (1) · Marcelo A Bello (1) · Richard J Fix, MD (1) · Terence M Myckatyn, M.D. (1)