Health TrialsbyHealthPanel

A Retrospective Assessment of OviTex PRS (OviTex)

ConditionReconstructive Surgical Procedures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorTela Bio Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial population

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

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • OviTex® PRS

    Device

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Retrospective - Prospective assessment

Time frame
24 months

Secondary outcomes

1

Time to Expander/Implant Exchange

Retrospective - Prospective assessment

Time frame
24-months
2

Intraoperative Fill Volume / Number and Volume of Fill Visits

Retrospective - Prospective assessment

Time frame
24 months
3

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

Image aesthetic assessment

Time frame
24 months
4

Independent assessment of breast ptosis as measured by the Rainbow Scale

Retrospective - Prospective assessment

Time frame
24-months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tela Bio Inc

Lead sponsor

MCRA

Collaborator

Source ClinicalTrials.gov
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