Sheep tissue device could improve breast reconstruction safety

NCT ID NCT07135596

Recruiting now Disease control Sponsor: Tela Bio Inc Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a device called OviTex PRS, made from sheep stomach tissue and polymer thread, for women having breast reconstruction after mastectomy. The goal is to see if it is safe and effective at reducing complications like reconstructive failure. About 235 women will take part in this research.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: OviTex PRS (a device made from sheep stomach tissue and polymer thread, used to support breast reconstruction)
What this could lead to: If successful, this could provide a safer, more effective option for women undergoing breast reconstruction after mastectomy.
What could go wrong: This is an early-stage study without a control group, so results may not be definitive. There is a risk of complications like reconstructive failure or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BREAST RECONSTRUCTION

Contacts and locations

Locations

Qualmedica Research
RECRUITING

Bowling Green, Kentucky, 42101, United States
WakeMed
RECRUITING

Raleigh, North Carolina, 27610, United States

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