Status:
RECRUITING
Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction
Lead Sponsor:
DOF Inc.
Conditions:
Breast Cancer Female
Breast Reconstruction
Eligibility:
FEMALE
19-79 years
Brief Summary
The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from diffe...
Detailed Description
Outline: The total number of study subjects is 120, with 60 people recruited prospectively into the test group and 60 people retrospectively into the control group. The test group will receive SC De...
Eligibility Criteria
Inclusion
- Prospective subjects (Test group) 1) Adult women aged 19 to 79 years. 2) Patients who received SC DERM® Recon, an acellular dermal matrix product, during breast reconstruction surgery with implants following a mastectomy due to breast cancer. 3) Individuals who have voluntarily provided written informed consent after receiving an explanation of the study's purpose and methods, are willing to comply with the study protocol, and are willing to visit the hospital for the evaluation of observational parameters.
- Retrospective Medical Record Collection 1) Patients who received an acellular dermal matrix product during breast reconstruction surgery with implants following a mastectomy due to breast cancer at Seoul National University Hospital between March 1, 2021, and March 31, 2024.
Exclusion
- Prospective subjects (Test group) 1) Individuals deemed inappropriate for study participation by the principal investigator or other investigator's judgement. (e.g., those unable to undergo the required tests for this study).
- Retrospective Medical Record Collection 1) Patients who received an acellular dermal matrix product but have no recorded follow-up visits after application.
Key Trial Info
Start Date :
June 13 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06555614
Start Date
June 13 2024
End Date
February 28 2027
Last Update
August 15 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080