A Retrospective Assessment of OviTex PRS (OviTex)
A Retrospective Assessment of OviTex PRS (OviTex) Permanent and Resorbable Devices in Subjects Who Have Previously Undergone a Breast Reconstruction
Tela Bio Inc
200 participants
Sep 27, 2022
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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).
- \. Patient agrees to return in-person for prospective portion including the completion of photographs.
Exclusion Criteria4
- 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.
- \. 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.
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Interventions
OviTex® 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.
Locations(11)
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NCT05736848