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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT00943150
Eligibility Criteria:
Inclusion Criteria:
1. Age between 25 and 60 years old
2. Physically healthy, stable weight, non-smoker
3. Protruding abdomen, excess fat and skin and/or weak abdominal muscles qualifying for abdominoplasty.
4. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
5. Subject must be willing and able to comply with specified follow-up evaluations.
6. Female subjects must either be no longer capable of reproduction or taking acceptable measures to prevent pregnancy during the study, and have a negative pregnancy test prior to participation in the study.
Exclusion Criteria:
1. Age younger than 25 or greater than 60 years old
2. Anticoagulation therapy which cannot be discontinued
3. Smoking (any kind)
4. Diabetes (any type)
5. Infection (local or systemic)
6. Cognitive impairment or mental illness
7. Severe cardiopulmonary deficiencies
8. Known coagulopathy
9. Immunocompromised
10. Kidney disease (any type)
11. Subjects who are pregnant or lactating
12. Currently taking any medication known to affect healing
13. Subjects who are status-post gastric banding or gastric bypass
14. Reproductive age females who will not take acceptable measures to prevent pregnancy during the study.
15. Recent history of abdominal surgery or prior abdominoplasty.
16. Subjects who are known to be HIV or Hepatitis (any) positive
17. Currently enrolled in another investigational device or drug trial
18. Unable to follow instructions or complete follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
60 Years
Study:
NCT00943150
Study Brief:
Protocol Section:
NCT00943150