NCT05736848

Brief Summary

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 Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Sep 2022Dec 2026

Study Start

First participant enrolled

September 27, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

3.8 years

First QC Date

January 23, 2023

Last Update Submit

August 14, 2025

Conditions

Reconstructive Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation.

    Retrospective - Prospective assessment

    24 months

Secondary Outcomes (5)

  • Time to Expander/Implant Exchange

    24-months

  • Intraoperative Fill Volume / Number and Volume of Fill Visits

    24 months

  • Independent aesthetic assessment of each treated breast as measured by Telemark Breast Score

    24 months

  • Independent assessment of breast ptosis as measured by the Rainbow Scale

    24-months

  • Hospitalization length of stay

    At procedure

Interventions

OviTex® PRSDEVICE

OviTex® PRS is a reinforced tissue matrix intended to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

Also known as: OviTex PRS Permanent - Pre-pectoral, OviTex PRS Permanent - Sub-pectoral, OviTex PRS Resorbable - Pre-pectoral, OviTex PRS Resorbable - Sub-pectoral

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Data will be collected for 200 subjects that have been implanted with OviTex® PRS

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • \. Patient agrees to return in-person for prospective portion including the completion of photographs.
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Aesthetic Surgery Center

Naples, Florida, 34108, United States

RECRUITING

Castrellon Aesthetic Surgery

South Miami, Florida, 33143, United States

RECRUITING

Y Plastic Surgery

Alpharetta, Georgia, 30005, United States

ACTIVE NOT RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Janineh Plastic Surgery

Rochester Hills, Michigan, 48307, United States

COMPLETED

David L. Abramson, MD

Englewood, New Jersey, 07631, United States

RECRUITING

Capital Health

Pennington, New Jersey, 08534, United States

RECRUITING

Strong Memorial Hospital

Rochester, New York, 14642, United States

COMPLETED

Plastic Surgery Consultants

Columbia, South Carolina, 29201, United States

RECRUITING

Dermatology Associates of San Antonio/Baptist Medical Center

San Antonio, Texas, 78256, United States

COMPLETED

Houston Methodist The Woodlands Hospital

The Woodlands, Texas, 77385, United States

RECRUITING

Study Officials

  • Asaf Yalif, MD

    Y Plastic Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zachary Sterner

CONTACT

937-514-2262zsterner@telabio.com

Danielle Campbell

CONTACT

717-676-2589dcampbell@telabio.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 21, 2023

Study Start

September 27, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(11)