Reconstructive Surgical ProceduresPRSNCT05736848
A Retrospective Assessment of OviTex PRS (OviTex)
An observational study of Reconstructive Surgical Procedures, run by Tela Bio Inc at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Reconstructive Surgical Procedures
- What is being tested?
- OviTex® PRS
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 11 sitesUnited States
- Study dates
- 27 Sep 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Adult, Older adult
Study population: Data will be collected for 200 subjects that have been implanted with OviTex® PRS
Who may be able to join
- 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).
Who cannot join
- 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.
- Additional prospective inclusion criteria (if applicable):
- 1. Patient agrees to return in-person for prospective portion including the completion of photographs.
- Additional prospective exclusion criteria (if applicable):
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Y Plastic Surgery
Alpharetta, Georgia, 30005
Massachusetts General Hospital
Boston, Massachusetts, 02114
Plastic Surgery Consultants
Columbia, South Carolina, 29201
David L. Abramson, MD
Englewood, New Jersey, 07631
Aesthetic Surgery Center
Naples, Florida, 34108
Capital Health
Pennington, New Jersey, 08534
Strong Memorial Hospital
Rochester, New York, 14642
Janineh Plastic Surgery
Rochester Hills, Michigan, 48307
Dermatology Associates of San Antonio/Baptist Medical Center
San Antonio, Texas, 78256
Castrellon Aesthetic Surgery
South Miami, Florida, 33143
Houston Methodist The Woodlands Hospital
The Woodlands, Texas, 77385
About this study
Official title: A Retrospective Assessment of OviTex PRS (OviTex) Permanent and Resorbable Devices in Subjects Who Have Previously Undergone a Breast Reconstruction
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.
Read the detailed description
This study is organized as a retrospective-prospective, observational, multi-center study. The treatment group involved in the study received OviTex PRS during implant-based breast reconstruction. The reconstruction procedure was an immediate or two-stage unilateral or bilateral implant in either the sub-pectoral or pre-pectoral position. Results from this study are aimed to demonstrate an acceptable safety profile and to inform the study design and effectiveness endpoints of a future prospective study.
- Conditions
- Reconstructive Surgical Procedures
- Being tested
- OviTex® PRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OviTex® PRSDevice
Also called OviTex PRS Permanent - Pre-pectoral, OviTex PRS Permanent - Sub-pectoral, OviTex PRS Resorbable - Pre-pectoral, OviTex PRS Resorbable - Sub-pectoral
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation.
Retrospective - Prospective assessment
Measured: 24 months
Secondary outcomes (5)
Time to Expander/Implant Exchange
Retrospective - Prospective assessment
Measured: 24-months
Intraoperative Fill Volume / Number and Volume of Fill Visits
Retrospective - Prospective assessment
Measured: 24 months
Independent aesthetic assessment of each treated breast as measured by Telemark Breast Score
Image aesthetic assessment
Measured: 24 months
Independent assessment of breast ptosis as measured by the Rainbow Scale
Retrospective - Prospective assessment
Measured: 24-months
Hospitalization length of stay
Retrospective - Prospective assessment
Measured: At procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start27 Sep 2022
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstructive Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tela Bio Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
- Investigators
- Asaf Yalif, MD, Principal investigator, Y Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736848
- Sponsor's protocol ID
- TB2022.01.02
- Acronym
- PRS
- Status last verified
- Aug 2026
- First submitted
- 23 Jan 2023
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Assessment of OviTex PRS (OviTex) Permanent and Resorbable Devices in Subjects Who Have Previously Undergone a Breast Reconstruction
- ClinicalTrials.gov ID
- NCT05736848
- Acronym / sponsor ID
- PRS / TB2022.01.02
- Conditions
- Reconstructive Surgical Procedures
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tela Bio IncIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is organized as a retrospective-prospective, observational, multi-center study. The treatment group involved in the study received OviTex PRS during implant-based breast reconstruction. The reconstruction procedure was an immediate or two-stage unilateral or bilateral implant in either the sub-pectoral or pre-pectoral position. Results from this study are aimed to demonstrate an acceptable safety profile and to inform the study design and effectiveness endpoints of a future prospective study.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Data will be collected for 200 subjects that have been implanted with OviTex® PRS
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
- 1. Patient agrees to return in-person for prospective portion including the completion of photographs.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OviTex® PRSAlso: OviTex PRS Permanent - Pre-pectoral, OviTex PRS Permanent - Sub-pectoral, OviTex PRS Resorbable - Pre-pectoral, OviTex PRS Resorbable - Sub-pectoralOviTex® 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. | Device | – |
Primary outcome
The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation.
Time frame: 24 months
Retrospective - Prospective assessment
5 secondary outcomes
Time to Expander/Implant Exchange
Time frame: 24-months
Intraoperative Fill Volume / Number and Volume of Fill Visits
Time frame: 24 months
Independent aesthetic assessment of each treated breast as measured by Telemark Breast Score
Time frame: 24 months
Independent assessment of breast ptosis as measured by the Rainbow Scale
Time frame: 24-months
Hospitalization length of stay
Time frame: At procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asaf Yalif, MD principal investigator
Y Plastic Surgery
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reconstructive Surgical Procedures, run by Tela Bio Inc at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.