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A Retrospective Assessment of OviTex PRS (OviTex)

← catalyst calendar

NCT05736848 · readout in 11 d

Sponsored by Tela Bio Inc (industry) · TELA — their whole pipeline →. With MCRA.

Phase
Status
Active, not recruiting
Study type
Observational
Enrollment
200estimated
Sites
11
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2022-09-27actualWhen the study began enrolling
Primary completion2026-08-30estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2026-12-31estimatedThe whole study's end, after follow-up
First posted2023-02-21actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-08-18actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Reconstructive Surgical Procedures

Intervention

  • Device: OviTex® PRS — also filed as OviTex PRS Permanent - Pre-pectoral, OviTex PRS Permanent - Sub-pectoral, OviTex PRS Resorbable - Pre-pectoral, OviTex PRS Resorbable - Sub-pectoral

Primary outcome

what the primary-completion date above is the date OF
The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation.
measured 24 months

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