Status:
RECRUITING
Evaluation of ADM(SC Derm® Recon) in Breast Reconstruction
Lead Sponsor:
DOF Inc.
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
20-80 years
Brief Summary
The goal of this observational study is to examine any clinical differences in the outcomes of breast reconstruction surgeries using Acellular Dermal Matrix (ADM) processed by CO2 supercritical fluid ...
Detailed Description
The total number of study subjects is 100, with 50 people recruited prospectively into the test group and 50 people retrospectively into the control group. The test group will consist of 50 patients ...
Eligibility Criteria
Inclusion
- 1\. Patients aged 20 to 80 who undergo immediate breast reconstruction using implants after taking total mastectomy
Exclusion
- Patients who fall into the five categories below cannot participate in this clinical study because they meet the exclusion criteria for research subjects.
- Patients who have received an organ transplant and are taking any immunosuppressant.
- Patients whose mental condition may affect the progress of clinical study due to alcohol or drug abuse.
- People who are unable to complete the survey conducted in this clinical study.
- Patients who participated in other clinical trials within the previous 120 days at the time of screening.
- If the investigator determine for a patient not to participate this clinical study since participation of the study is not appropriate.
Key Trial Info
Start Date :
June 12 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06553859
Start Date
June 12 2023
End Date
June 1 2025
Last Update
August 14 2024
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 05505