Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2022-09-27
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
RETROSPECTIVE
Interventions
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OviTex® PRS
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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. Patient has undergone their initial surgical procedure and exchange surgery (if applicable).
1\. Patient agrees to return in-person for prospective portion including the completion of photographs.
Exclusion Criteria
2. Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure.
3. Patient had previously undergone radiation therapy to the chest wall prior to index surgery.
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.
18 Years
75 Years
FEMALE
No
Sponsors
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MCRA
INDUSTRY
Tela Bio Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Asaf Yalif, MD
Role: PRINCIPAL_INVESTIGATOR
Y Plastic Surgery
Locations
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Aesthetic Surgery Center
Naples, Florida, United States
Castrellon Aesthetic Surgery
South Miami, Florida, United States
Y Plastic Surgery
Alpharetta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Janineh Plastic Surgery
Rochester Hills, Michigan, United States
David L. Abramson, MD
Englewood, New Jersey, United States
Capital Health
Pennington, New Jersey, United States
Strong Memorial Hospital
Rochester, New York, United States
Plastic Surgery Consultants
Columbia, South Carolina, United States
Dermatology Associates of San Antonio/Baptist Medical Center
San Antonio, Texas, United States
Houston Methodist The Woodlands Hospital
The Woodlands, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TB2022.01.02
Identifier Type: -
Identifier Source: org_study_id
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