Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT04115995
Eligibility Criteria:
Inclusion Criteria:
* Post mastectomy.
* Previously breast cancer patent treated with radiation therapy.
* Breast implant reconstruction is not possible or undesired.
* Healthy patient with moderate amounts of abdominal skin laxity.
* Patient who requires a minimal to moderate volume breast reconstruction.
* The patient willing to undergo the long, complex procedure and prolonged postoperative recovery.
* The patient willing to accept an abdominal scar and a potential for donor site morbidities.
* Patients operated with prophylactic salpingo-oophorectomy due to BRCA gene mutation.
Exclusion Criteria:
* Pregnancy and lactation.
* Patents below the age of 18 year.
* Renal failure or hepatic failure.
* Previous allergic reactions to ICG and iodide.
* Abdominal donor site that cannot be closed primarily.
* Previous TRAM flap or abdominoplasty.
* Significant medical comorbidities that make the patient a poor surgical candidate.
* Sigarette smoking or snuff.
* Obesity / BMI \> 30.
* Previous abdominal suction-assisted lipectomy.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
70 Years
Study:
NCT04115995
Study Brief:
Protocol Section:
NCT04115995