Patients with unwanted visceral fat 448 KHz, visceral fat reduction, radiofrequency
Conditions
Interventions
Volunteers will be treated using a monopolar radiofrequency system operating at a frequency of 448 kHz. A resistive electrode (stainless steel applicator) will be applied directly to the participants
Experimental Device
Radiofrequency
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
30 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Age 30 - 55 years 2. Body mass index (BMI) 18.5 - 24.9 kg/m2
Exclusion criteria
Exclusion criteria: 1. Participants with body weight changes greater than 3 kg within the past month 2. Participants who are pregnant, within 3 months postpartum, breastfeeding, or planning to become pregnant 3. Participants with a history of surgery in the study area within the past 1 year 4. Participants with a history of implanted metal devices, intrauterine devices (IUDs), cardiac - pacemakers, or electrically powered medical devices 5. Participants with wounds, skin infections, or dermatologic conditions at the study site 6. Participants with psychiatric disorders who are unable to remain still or cooperate during device use 7. Participants with a history of cancer, diabetes mellitus, or chronic kidney disease 8. Participants with abdominal hernia, peripheral vascular disease, heart disease, epilepsy, or any condition deemed by the investigator to pose a safety risk for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight Baseline, 1 wk, 4 wk, 12 wk, 24 wk follow up kg ,Waist circumference Baseline, 1 wk, 4 wk, 12 wk, 24 wk follow up inch,Fat mass Baseline, 1 wk, 4 wk, 12 wk, 24 wk follow up Bioimpedence ,Xray film at L4 level baseline, 1 wk follow up Determine fat mass | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety 1st-10th treatment, 1 wk, 12 wk, 24 wk follow up Adverse event,Patient Improvement scale Baseline, 1 wk, 4 wk, 12 wk, 24 wk follow up percent improvement,Physician Improvement scale Baseline, 1 wk, 12 wk, 24 wk follow up percent improvement | — |
Countries
Thailand
Contacts
Public ContactRungsima Wanitphakdeedecha
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed