Status:
RECRUITING
Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction
Lead Sponsor:
DOF Inc.
Conditions:
Breast Cancer Female
Breast Reconstruction
Eligibility:
FEMALE
20-69 years
Brief Summary
This is the multi-centered, open, prospective and retrospective study of up to total 120 subjects in breast reconstruction surgery with applying acellular dermal matrix(ADM). The aim of the study is t...
Detailed Description
In South Korea, breast reconstruction surgery using implants or autologous abdominal tissue is commonly performed as the standard treatment to address the aesthetic and psychological needs of breast c...
Eligibility Criteria
Inclusion
- Female patients aged 20 to 69 scheduled for total mastectomy
- Patients who are willing to undergo immediate breast reconstruction using implants.
Exclusion
- Patients who have undergone organ transplantation and are currently taking immunosuppressive medication.
- Patients with mental conditions that could impact the conduct of the clinical study, such as alcohol or drug abuse.
- Patients who have participated in another clinical trial within 120 days prior to screening.
- Any other cases where the investigator deems the patient unsuitable for this clinical study.
Key Trial Info
Start Date :
January 4 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06555692
Start Date
January 4 2024
End Date
December 31 2025
Last Update
August 15 2024
Active Locations (1)
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1
Soon Chun Hyang University Hospital
Seoul, South Korea, 04401