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:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT06265558
Eligibility Criteria:
Inclusion Criteria:
1. Female ≥ 18 years
2. Patient with unilateral invasive or in situ breast carcinoma
3. Patient with or without neoadjuvant treatment
4. Patient presenting an indication for complex breast surgery by mastectomy with immediate breast reconstruction by implant or oncoplasty by T-shaped mammoplasty.
5. Patient presenting at least one of the following risk factors for scarring disorders:
* Obesity with Body Mass Index BMI ≥ 30 and/or Cup size ≥ E
* Active smoking or smoking cessation for less than one month
* Diabetes
* History of homolateral breast radiotherapy
* Long-term corticosteroid therapy
6. Patient to have signed informed consent prior to study entry
7. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
8. Patient affiliated with a health insurance plan.
Exclusion Criteria:
1. Legal incapacity or limited legal capacity. Medical or psychological conditions preventing the patient from completing the study or signing the consent form.
2. Pregnant or breast-feeding patient as determined in medical records as part of standard patients care and follow-up
3. Patient under guardianship or safeguard of justice
4. Patient participating in an interventional study with the objective of wound healing
5. Any concurrent or planned surgical procedure on the contralateral breast
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06265558
Study Brief:
Protocol Section:
NCT06265558