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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT00616135
Eligibility Criteria:
Inclusion Criteria:
* Females with a history of T2N0M0 breast carcinoma (tumor ≤3 cm in largest dimension)
* Surgical or endoscopic segmental mastectomy or quadrantectomy (lumpectomy)
* Clean surgical margins
* No prosthesis in breast(s) to undergo treatment
* Ability to undergo lipoaspiration
* Last treatment for breast cancer ≥ 12 months prior to enrollment with absence of recurrence (patients on anti-estrogen adjuvant therapy are NOT excluded)
* No evidence of recurrence of cancer based on mammogram or breast exam prior to enrollment
* Objective signs of mild breast damage post Breast Conservation Therapy
* Type I Cosmetic Sequelae Classification
* A minimum of 1 cm of soft tissue (e.g. breast or fat) is available between the skin and chest wall at the recipient site
* A minimum of two-thirds of the breast is remaining post Breast Conservation Therapy
* No continuous adhesion of skin to bone \>3 cm in diameter
* The volume and shape of the defect(s) must be conducive to correction during a single treatment session (maximum defect volume ≤150 mL in breast(s) to undergo treatment)
Exclusion Criteria:
* History of autoimmune disorder (e.g., Systemic Lupus Erythematosus \[SLE\])
* History of connective, metabolic or atrophic skin disease
* History of keloid scarring
* Chronic use (\>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days prior to enrollment
* Life expectancy ≤ 2 years
* Recurrence or active malignancy requiring radiation or surgical treatment ≤12 months prior to enrollment
* Presence of any other known malignancy
* Body Mass Index (BMI) \>30
* Plan to undergo weight reduction surgery or foresee any significant weight changes during the study (defined as changes in BMI \>5 compared to baseline
* Presence of contraindications to MRI
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00616135
Study Brief:
Protocol Section:
NCT00616135