Clinical trial NCT06152900: Safety and Efficacy of Electronic Stimulation for Circumferential Reduction and Muscle Toning
Official title: Clinical Evaluation of the Safety and Efficacy of Electronic Stimulation for Non-Invasive Circumferential Reduction and Muscle Toning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Necrosis
Muscle Stimulation
Lead sponsor: LUTRONIC Corporation
Sponsor class: INDUSTRY
First posted: 2023-12-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open-label, baseline-controlled, multi-center study evaluating an electrical muscle stimulation system for circumferential reduction and muscle toning. The study will enroll up to 100 subjects desiring circumferential reduction and muscle toning. Each subject will receive up to 12 bi-weekly treatments over a 6-week period. Follow Up Visits planned for 2, 30- and 90-days post treatment. Measurement outcomes will be compared to baseline.


Eligibility criteria: Inclusion Criteria:

1. Able to read, understand and voluntarily provide written informed consent.
2. Healthy male or female, ≥ 18 years to 65 years of age seeking treatment for improved muscle strength and muscle toning in their core and extremities.
3. Subject is determined to be physically fit and agrees to not making any major changes in their diet or lifestyle during the study.
4. Able and willing to comply with the treatment/follow-up schedule and requirements.
5. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study as well as have a negative Urine Pregnancy test at baseline.

Exclusion Criteria:

1. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months.
2. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.
3. History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) or use of immunosuppressive medications, 6 months prior to and during the study.
4. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
5. Having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or premalignant pigmented lesions.
6. Having a permanent implant in the treatment area such as metal plates or an injected chemical substance such as silicone in the treatment area.
7. 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.
8. Poor skin quality (severe laxity).
9. Abdominal wall, muscular abnormality or hernia on physical examination.
10. As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate.
11. Subjects unwilling or unable to adhere to all study requirements for treatment and follow-up.
12. Investigator may exclude any subject at any time at his/her discretion.

Primary outcomes:
measure: Photographic Evaluation
timeFrame: Baseline, 48-hours post treatment, 30-day FU, 90-day FU
Secondary outcomes:
measure: Circumferential Reduction
timeFrame: Baseline, 30-day FU, 90-day FU
measure: Subject Satisfaction
timeFrame: 30-day FU, 90-day FU
measure: Global Aesthetic Improvement Scale
timeFrame: 30-day FU, 90-day FU
measure: Muscle Strength
timeFrame: Baseline, 30-day FU, 90-day FU
Other outcomes:
Locations:
city: Billerica
country: United States
facility: Lutronic US Headquarters
state: Massachusetts
city: New York
country: United States
facility: Union Square Dermatology
state: New York
Study officials:
References: