Clinical trial NCT05736848: A Retrospective Assessment of OviTex PRS (OviTex)
Official title: A Retrospective Assessment of OviTex PRS (OviTex) Permanent and Resorbable Devices in Subjects Who Have Previously Undergone a Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Reconstructive Surgical Procedures
Lead sponsor: Tela Bio Inc
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2023-02-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be collected for 200 subjects that have been implanted with OviTex® PRS

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patient was between 18 years and 75 years of age (inclusive) at the time of surgery.
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).

Exclusion Criteria:

1. Patient received a textured permanent breast implant.
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.

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.

Primary outcomes:
measure: The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation.
timeFrame: 24 months
Secondary outcomes:
measure: Time to Expander/Implant Exchange
timeFrame: 24-months
measure: Intraoperative Fill Volume / Number and Volume of Fill Visits
timeFrame: 24 months
measure: Independent aesthetic assessment of each treated breast as measured by Telemark Breast Score
timeFrame: 24 months
measure: Independent assessment of breast ptosis as measured by the Rainbow Scale
timeFrame: 24-months
measure: Hospitalization length of stay
timeFrame: At procedure
Other outcomes:
Locations:
city: Naples
country: United States
facility: Aesthetic Surgery Center
state: Florida
city: South Miami
country: United States
facility: Castrellon Aesthetic Surgery
state: Florida
city: Alpharetta
country: United States
facility: Y Plastic Surgery
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester Hills
country: United States
facility: Janineh Plastic Surgery
state: Michigan
city: Englewood
country: United States
facility: David L. Abramson, MD
state: New Jersey
city: Pennington
country: United States
facility: Capital Health
state: New Jersey
city: Rochester
country: United States
facility: Strong Memorial Hospital
state: New York
city: Columbia
country: United States
facility: Plastic Surgery Consultants
state: South Carolina
city: San Antonio
country: United States
facility: Dermatology Associates of San Antonio/Baptist Medical Center
state: Texas
city: The Woodlands
country: United States
facility: Houston Methodist The Woodlands Hospital
state: Texas
Study officials:
affiliation: Y Plastic Surgery
name: Asaf Yalif, MD
role: PRINCIPAL_INVESTIGATOR
References: