A Retrospective Assessment of OviTex PRS (OviTex)
ConditionReconstructive Surgical Procedures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorTela Bio Inc
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- OviTex® PRS
Treatment groups
No treatment groups listed
Sponsors and collaborators
Tela Bio Inc
Lead sponsor
MCRA
Collaborator
Source ClinicalTrials.gov