MedTrace Logo

STARS-R Registry: Retrospective Analysis of Poly-4-hydroxybutyrate (P4HB) Scaffold Use

NCT04195854 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1183

Last updated 2022-02-04

No results posted yet for this study

Summary

This is a retrospective chart review performed at multiple clinics aimed at providing real-world evidence of the use and safety of the P4HB scaffold. Data on patient demographics, relevant medical history, product and procedure used, product safety, and outcome measures will be collected as available.

Conditions

  • Plastic Surgery
  • Reconstructive Surgery

Interventions

DEVICE

P4HB product

Retrospective use of P4HB in various anatomies

Sponsors & Collaborators

  • Tepha, Inc.

    collaborator INDUSTRY

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • K Doyle · Tepha, Inc/Galatea Surgical

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-17
Primary Completion
2022-01-31
Completion
2022-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04195854 on ClinicalTrials.gov