RECRUITING

A Retrospective Assessment of OviTex PRS (OviTex)

Talk to us

Conditions

Reconstructive Surgical Procedures

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Retrospective Assessment of OviTex PRS (OviTex) Permanent and Resorbable Devices in Subjects Who Have Previously Undergone a Breast Reconstruction

Quick Facts

Study Start:2022-09-27
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05736848

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient was between 18 years and 75 years of age (inclusive) at the time of surgery.
  2. 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.
  3. 3. Patient has undergone their initial surgical procedure and exchange surgery (if applicable).
  1. 1. Patient received a textured permanent breast implant.
  2. 2. Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure.
  3. 3. Patient had previously undergone radiation therapy to the chest wall prior to index surgery.
  4. 1. Patient agrees to return in-person for prospective portion including the completion of photographs.
  5. 1. 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.

Contacts and Locations

Study Contact

Zachary Sterner
CONTACT
937-514-2262
zsterner@telabio.com
Danielle Campbell
CONTACT
717-676-2589
dcampbell@telabio.com

Principal Investigator

Asaf Yalif, MD
PRINCIPAL_INVESTIGATOR
Y Plastic Surgery

Study Locations (Sites)

Y Plastic Surgery
Alpharetta, Georgia, 30005
United States
Janineh Plastic Surgery
Rochester Hills, Michigan, 48307
United States
David L. Abramson, MD
Englewood, New Jersey, 07631
United States
Strong Memorial Hospital
Rochester, New York, 14642
United States
Plastic Surgery Consultants
Columbia, South Carolina, 29201
United States
Dermatology Associates of San Antonio/Baptist Medical Center
San Antonio, Texas, 78256
United States
Houston Methodist The Woodlands Hospital
The Woodlands, Texas, 77385
United States

Collaborators and Investigators

Sponsor: Tela Bio Inc

  • Asaf Yalif, MD, PRINCIPAL_INVESTIGATOR, Y Plastic Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-27
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-09-27
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Reconstructive Surgical Procedures