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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT03588702
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male or female older than 18 years of age but not older than 65 years of age.
2. Having suitable area for treatment (bilateral liposuction of the back, flanks or thighs performed 8 weeks prior to study).
3. BMI score is greater than 18.5 and less than 29.9.
4. Willingness to refrain from a change in diet/drinking/exercise/medication regimen for the entire course of the study.
Exclusion Criteria:
1. Pregnant or planning to become pregnant, having given birth (vaginal birth or Caesarean surgery) less than 9 months ago, and/or breastfeeding.
2. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
3. Having a permanent implant in the treated areas, such as metal plates and screws or an injected chemical substance.
4. Having undergone any other surgery in the treated areas within 9 months of treatment or during the study.
5. Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
6. Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders.
7. Having a known anti-coagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course.
8. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
9. Suffering from hormonal imbalance which may affect weight or cellulite.
10. History of significant lymphatic drainage problems.
11. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions and active cold sores or herpes sores prior to treatment or during the treatment course.
12. History of keloid scarring or of abnormal wound healing.
13. History of being especially prone to bruising.
14. History of epidermal or dermal disorders (particularly if involving collagen or micro-vascularity).
15. Use of oral retinoids (e.g. isotretinoin (Accutane®)) within 6 months of treatment or during the study.
16. Use of anti-cellulite creams within a month of treatment or during the course of the study.
17. Significant change in diet or exercise regimen within a month of enrollment or during this study and/or weight loss or gain of 10 lbs. (4.5 kgs) within 2 months of enrollment or during this study.
18. Participation in a study of another device or drug within 1 month prior to enrollment or during this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03588702
Study Brief:
Protocol Section:
NCT03588702