Effectiveness and Safety of OviTex® PRS in Breast Reconstruction

Part of paid clinical trials in Bowling Green, Kentucky.

Sponsor
Tela Bio Inc
Study ID
NCT07135596
Status
Recruiting
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Conditions

  • Breast Reconstruction

Eligibility Criteria

Sex
FEMALE
Age
22 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • OviTex PRS — DEVICE
    A multi-layer construct of extracellular matrix (ECM) derived from ovine forestomach and embroidered with polymer filament.

Study Details

The purpose of this study is to evaluate the safety and effectiveness of OviTex PRS in subjects undergoing implant-based breast reconstruction.

Key Dates

Start date
Apr 10, 2026
Status verified
May 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2034

Study Design

Enrollment
235 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: OviTex PRS

Primary Outcome Measure

Reconstructive Failure Rate [ Time Frame: From enrollment to 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Qualmedica ResearchBowling GreenKentucky42101
Troy Gunter
[email protected]
270-904-4334
Katherine Durnen, MD (PRINCIPAL_INVESTIGATOR)
WakeMedRaleighNorth Carolina27610
Rhonda Norton
[email protected]
919-350-5252
Corianne Rogers, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Bowling Green, KY

By research site
Qualmedica Research· Bowling Green, KYWakeMed· Raleigh, NC

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