A Retrospective Assessment of OviTex PRS (OviTex)

Recruiting now

Conditions studied: Reconstructive Surgical Procedures

In brief

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 facts

Study ID

NCT05736848

Run by

Tela Bio Inc

People needed

200

Starts

2022-09-27

Expected to finish

2026-12-31

Last updated by the study team

2025-08-15

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patient was between 18 years and 75 years of age (inclusive) at the time of surgery.
• At the time of surgery, the patient received an OviTex PRS Permanent (R20143 or R20243) or Resorbable (R20152 or R20252) implant in conjunction with an implant-based breast reconstruction.
• Patient has undergone their initial surgical procedure and exchange surgery (if applicable).

You may not qualify if…

• Patient received a textured permanent breast implant.
• Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure.
• Patient had previously undergone radiation therapy to the chest wall prior to index surgery.
• Additional prospective inclusion criteria (if applicable):
• Patient agrees to return in-person for prospective portion including the completion of photographs.
• Additional prospective exclusion criteria (if applicable):
• Patient has a history of a psychological condision, drug or alcohol abuse which may interfere with their ability to adhere to the follow-up requirements.

Where it is running

• Houston Methodist The Woodlands Hospital — The Woodlands, Texas, United States (enrolling)
• Castrellon Aesthetic Surgery — South Miami, Florida, United States (enrolling)
• David L. Abramson, MD — Englewood, New Jersey, United States (enrolling)
• Capital Health — Pennington, New Jersey, United States (enrolling)
• Plastic Surgery Consultants — Columbia, South Carolina, United States (enrolling)
• Aesthetic Surgery Center — Naples, Florida, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Y Plastic Surgery — Alpharetta, Georgia, United States
• Dermatology Associates of San Antonio/Baptist Medical Center — San Antonio, Texas, United States
• Janineh Plastic Surgery — Rochester Hills, Michigan, United States
• Strong Memorial Hospital — Rochester, New York, United States

Full record on ClinicalTrials.gov

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