Phase
Condition
N/ATreatment
OviTex® PRS
Clinical Study ID
Ages 18-75 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 orR20243) or Resorbable (R20152 or R20252) implant in conjunction with animplant-based breast reconstruction.
Patient has undergone their initial surgical procedure and exchange surgery (ifapplicable).
Exclusion
Exclusion Criteria:
Patient received a textured permanent breast implant.
Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weekspreceeding their index procedure.
Patient had previously undergone radiation therapy to the chest wall prior to indexsurgery.
Additional prospective inclusion criteria (if applicable):
- Patient agrees to return in-person for prospective portion including the completionof photographs.
Additional prospective exclusion criteria (if applicable):
- Patient has a history of a psychological condision, drug or alcohol abuse which mayinterfere with their ability to adhere to the follow-up requirements.
Study Design
Study Description
Connect with a study center
Aesthetic Surgery Center
Naples, Florida 34108
United StatesActive - Recruiting
Castrellon Aesthetic Surgery
South Miami, Florida 33143
United StatesActive - Recruiting
Y Plastic Surgery
Alpharetta, Georgia 30005
United StatesSite Not Available
Y Plastic Surgery
Atlanta, Georgia 30342
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Janineh Plastic Surgery
Rochester Hills, Michigan 48307
United StatesCompleted
David L. Abramson, MD
Englewood, New Jersey 07631
United StatesActive - Recruiting
Capital Health
Pennington, New Jersey 08534
United StatesActive - Recruiting
Stong Memorial Hospital
Rochester, New York 14642
United StatesActive - Recruiting
Strong Memorial Hospital
Rochester, New York 14642
United StatesCompleted
Plastic Surgery Consultants
Columbia, South Carolina 29201
United StatesActive - Recruiting
Dermatology Associates of San Antonio/Baptist Medical Center
San Antonio, Texas 78256
United StatesCompleted
Houston Methodist The Woodlands Hospita
The Woodlands, Texas 77385
United StatesActive - Recruiting
Houston Methodist The Woodlands Hospital
The Woodlands, Texas 77385
United StatesActive - Recruiting
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