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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT03544593
Eligibility Criteria:
Inclusion Criteria:
1. Females or Males in good general health age 18 - 65 years of age
2. Must be willing to give and sign a HIPAA form and informed consent form
3. Must be willing and able to comply with all study protocols and schedules
4. Negative urine pregnancy test prior to surgery treatment (if applicable)
5. The patient must have had a stable weight (no fluctuation of \>15 pounds in a year), diet, and physical activity for the previous 6 months
Exclusion Criteria:
1. Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial
2. History of breast cancer if fat grafting to breasts
3. Patients who smoke or use nicotine products
4. Any UNCONTROLLED systemic disease -a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
5. Diabetes Mellitus
6. Subject has a clinically significant coagulation disorder or disease, defined as a platelet count \< 100,000 per microliter or International Normalized Ratio \> 1.5 within 4 weeks of surgery
7. Patients under the age of 18
8. Patients undergoing fat grafting but refuse enrollment
9. Patients with an active infection
10. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03544593
Study Brief:
Protocol Section:
NCT03544593