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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT02873104
Eligibility Criteria:
Inclusion Criteria:
* Female or Male, 24 to 60 years of age (inclusive). Fitzpatrick Skin Type I - VI. Has visible fat bulges on the abdomen and palpable fat pockets superior to iliac crest located bilaterally in the lower back flank region Has a Body Mass Index (BMI) ≥ 20 and ≤ 30 Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.
Subject must agree to not undergo any other procedure(s) in the abdominal and flank region during the study period.
Subject must be able to read, understand and sign the Informed Consent Form. Subject must adhere to the follow-up schedule and study instructions. Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study, within 5% of baseline weight measurement.
Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant.
Exclusion Criteria:
* Participation in a clinical trial of another device or drug within 6 months of study participation, or during the study period.
Any type of prior cosmetic treatment to the target area within 12 months of study participation e.g., radiofrequency, cryolysis or light-based treatments.
Any prior invasive cosmetic surgery to the target area, such as liposuction. Currently taking medications or supplements for weight-loss or metabolism support/enhancement or has a history of taking such medications or supplements within 3 months.
Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
Has metal implant(s) within the body, such as surgical clips, plates and screws, intrauterine device (IUD), artificial heart valves or artificial joints.
Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders.
Diagnosed or documented immune system disorders. History of any disease or condition that could impair wound healing. History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.
Infection, dermatitis, rash or other skin abnormality in the target area. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
Pregnant or currently breastfeeding. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
24 Years
Maximum Age:
60 Years
Study:
NCT02873104
Study Brief:
Protocol Section:
NCT02873104