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 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT03756350
Eligibility Criteria:
Inclusion Criteria:
* able to read, understand and voluntarily provide written informed consent
* healthy male or female \> 18 years of age seeking treatment for unwanted fat in the abdomen
* BMI score is less then 30
* agree to not making any major changes in their diet or lifestyle during the course of the study
* able and willing to comply with the treatment / follow up schedule and requirements
* women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrolment and for the duration of the study, have a negative urine pregnancy test baseline
Exclusion Criteria:
* pregnant in the last 3 months intending to become pregnant, postpartum or nursing in the last 6 months
* any previous liposuction / lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months
* history of immunosuppression / immune deficiency disorders including AIDS and HIV infection, or use of immunosuppressive medications, 6 month prior to and during the course of the study
* History of hyperlipidemia, diabetes, hepatitis, blood coagulopathy or excessive bleeding
* Use of antiplatelet medications (81 mg of acetylsalicylic acid daily is permitted), anticoagulants, thrombocytes or any-inflammatory medications within 2 weeks of treatment
* Having a history of skin cancer or any other cancer in the area to be treated, including presence of malignant or pre-malignant pigmented lesions
* Having a permanent implant in the treatment area such as a metal plate or injected chemical substance such as silicone pr parenteral gold therapy (gold sodium thiomalate)
* Use of medications, herbs or food supplements and vitamins known to induce photosensitivity to light exposure at the wavelength used history of photosensitivity disorder
* Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections
* Tattoos in the treatment area
* Poor quality skin (laxity)
* Abdominal wall, muscular abnormality or hernia on physical examination
* Unstable weight within the last 6 months (+ or - 3% weight change in the prior six months)
* Participation in another clinical study involving the same anatomical areas within the last 6 months
* History of keloid and hypertrophic scar formation or poor wound healing in the treatment area
* As per the investigators discretion any physician or mental condition which may make it unsafe for the subject to participate
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03756350
Study Brief:
Protocol Section:
NCT03756350