A Retrospective Assessment of OviTex PRS (OviTex)
Part of paid clinical trials in Naples, Florida.
- Sponsor
- Tela Bio Inc
- Study ID
- NCT05736848
- Status
- Recruiting
Conditions
- Reconstructive Surgical Procedures
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- OviTex® PRS — DEVICEOviTex® PRS is a reinforced tissue matrix intended to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
Study Details
The objective of this retrospective-prospective, observational study is to evaluate the safety profile overall and within two device types of OviTex PRS in previous pre-pectoral or sub-pectoral implant-based breast reconstructions.
Key Dates
- Start date
- Sep 27, 2022
- Status verified
- Aug 2025
- Primary completion
- Jun 30, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 200 participants (estimated)
Primary Outcome Measure
The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation. [ Time Frame: 24 months ]
Central Contacts
- Zachary Sterner937-514-2262
- Danielle Campbell717-676-2589
Locations (11)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Aesthetic Surgery Center | Naples | Florida | 34108 | Casey Holmes, MD (PRINCIPAL_INVESTIGATOR) |
| Castrellon Aesthetic Surgery | South Miami | Florida | 33143 | Ricardo Castrellon, MD, P.A. (PRINCIPAL_INVESTIGATOR) |
| Y Plastic Surgery | Alpharetta | Georgia | 30005 | - |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Matthew DePamphilis Katherine Carruthers, MD (PRINCIPAL_INVESTIGATOR) |
| Janineh Plastic Surgery | Rochester Hills | Michigan | 48307 | - |
| David L. Abramson, MD | Englewood | New Jersey | 07631 | Zoe Robertson David Abramson, MD (PRINCIPAL_INVESTIGATOR) |
| Capital Health | Pennington | New Jersey | 08534 | Gary Tuma, MD, FACS (PRINCIPAL_INVESTIGATOR) |
| Strong Memorial Hospital | Rochester | New York | 14642 | - |
| Plastic Surgery Consultants | Columbia | South Carolina | 29201 | Samantha Schneider Richard Wassermann, MD (PRINCIPAL_INVESTIGATOR) |
| Dermatology Associates of San Antonio/Baptist Medical Center | San Antonio | Texas | 78256 | - |
| Houston Methodist The Woodlands Hospital | The Woodlands | Texas | 77385 | Jennifer Garrett Steven Albright, MD (PRINCIPAL_INVESTIGATOR) |