Trials / Completed
CompletedNCT05182177
The SurgiMend PRS Retrospective Study
A Multi-Center, Retrospective Review of Implant-Based Post Mastectomy Breast Reconstruction Utilizing SurgiMend® Collagen Matrix in Prepectoral and Submuscular Surgical Approaches
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 84 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The SurgiMend® PRS Retrospective Study will evaluate the performance and safety of SurgiMend® PRS and SurgiMend® PRS Meshed when used for soft tissue reinforcement under the product's indications for use.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SurgiMend PRS | SurgiMend® PRS and SurgiMend® PRS Meshed are intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend® PRS and SurgiMend® PRS Meshed are specifically indicated for plastic and reconstructive surgery, including breast reconstruction. |
Timeline
- Start date
- 2022-01-31
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
- First posted
- 2022-01-10
- Last updated
- 2025-02-14
Locations
6 sites across 3 countries: Italy, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT05182177. Inclusion in this directory is not an endorsement.