A Retrospective Assessment of OviTex PRS (OviTex)

Recruiting Observational Study
Reconstructive Surgical Procedures
No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 – 75
Sex
Female
Study type
Observational
Participants needed
200 (estimated)
Sponsor
Tela Bio Inc · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patient was between 18 years and 75 years of age (inclusive) at the time of surgery. 2. 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.…
Contacts

Zachary Sterner

937-514-2262

zsterner@telabio.com

CONTACT

Danielle Campbell

717-676-2589

dcampbell@telabio.com

CONTACT