Stopped: It wasn't possible to recruit the desired number of patients.
The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and four follow-up visits, 1 month, 3, 6 and 12 months after the final treatment. At the baseline visit photographs of the abdomen will be taken. In addition, patient umbilical circumference will be measured and the subject's weight will be recorded. In addition, at the last therapy visit, subjects will receive Subject Satisfaction and Therapy Comfort Questionnaires to fill in. Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after the procedure. Following each treatment administration and at the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment. Post-procedure evaluation (follow-up visits) will be conducted 1 month, 3, 6 and 12 months after the final treatment. Umbilical circumference and weight measure will be conducted at every follow-up visit. Also, subject's satisfaction will be noted. During the first (1 month), third (6 months) and last (12 months) follow-up visits, photographs of abdomen will be taken.
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Effectiveness of the device assessed through photography evaluation
Timeframe: 13 months
Effectiveness of the device assessed through change in adipose/muscle layer thickness
Timeframe: 13 months
Subject's satisfaction
Timeframe: 13 months