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A Prospective Study on the Safety and Efficacy of HIFEM + Technique for Abdominal and Buttock Muscle Configuration

A Prospective Study on the Safety and Efficacy of HIFEM + Technique for Abdominal and Buttock Muscle Configuration

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099324
Enrollment
Unknown
Registered
2025-03-21
Start date
2024-07-05
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy subjects

Interventions

Self before and after comparison:High-intensity electromagnetic fields (HIFEM) and simultaneous radiofrequency technology (Emsculpt NEO, BTL Industries Inc.) are used to treat the abdomen and/or butto

Sponsors

Shanghai Ninth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
22 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Men or women between the ages of 22 and 65 who wish to shape their abdominal and/or hip muscles; 2.The weight change in the month before the study began was no more than 5% of body weight; 3.The body mass index (BMI) is less than 30 kg/m^2; 4. Be willing and able to maintain a daily (pre-treatment) diet and exercise regimen without affecting significant changes in any direction during study participation; 5. Volunteer to participate in this study and sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1. Those who are pregnant and plan to become pregnant within 6 months, and those who give birth naturally or by caesarean section within 6 months; 2.Surgical procedures (e.g. abdominoplasty, rectus abdominis separation and correction, abdominal wall hernia repair, etc.), invasive fat reduction or filler surgery, non-invasive fat reduction surgery, etc. in or near the treatment area in the past 6 months; 3. Heart disease, pulmonary insufficiency, and metal implants or active implant devices, such as intrauterine contraceptive devices, pacemakers, defibrillators, or drug delivery systems; 4. Known mixed cryoglobulinemia, cold-induced urticaria, cold agglutinin disease, paroxysmal cold hemoglobinuria, Raynaud's disease, bleeding disorders or concomitant medications that may increase the risk of bruising, skin conditions such as excessive skin sagging or scarring that may interfere with treatment or evaluation, history of abnormal wound healing; 5. Participated in any type of abdominal and/or hip muscle training program within the past three months.

Design outcomes

Primary

MeasureTime frame
Abdominal and/or Hip of Global Aesthetic Improvement Scale (GAIS);Muscle tissue remodeling;

Secondary

MeasureTime frame
Circumference (abdominal circumference/hip circumference);body mass index;visceral fat area;Subject Experience Questionnaire;

Countries

China

Contacts

Public ContactMin Yao

Shanghai Ninth People's Hospital

my058@vip.sina.com+86 189 1779 7606

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026