Status:
COMPLETED
Safety and Efficacy of Electronic Stimulation for Circumferential Reduction and Muscle Toning
Lead Sponsor:
LUTRONIC Corporation
Conditions:
Fat Necrosis
Muscle Stimulation
Eligibility:
All Genders
18-65 years
Phase:
NA
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 desirin...
Eligibility Criteria
Inclusion
- Able to read, understand and voluntarily provide written informed consent.
- 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.
- Subject is determined to be physically fit and agrees to not making any major changes in their diet or lifestyle during 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 enrollment and for the duration of the study as well as have a negative Urine Pregnancy test at baseline.
Exclusion
- 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 months prior to and during the study.
- History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
- Having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or premalignant pigmented lesions.
- Having a permanent implant in the treatment area such as metal plates or an injected chemical substance such as silicone in the treatment area.
- 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.
- Poor skin quality (severe laxity).
- Abdominal wall, muscular abnormality or hernia on physical examination.
- As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate.
- Subjects unwilling or unable to adhere to all study requirements for treatment and follow-up.
- Investigator may exclude any subject at any time at his/her discretion.
Key Trial Info
Start Date :
October 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06152900
Start Date
October 5 2021
End Date
November 20 2023
Last Update
December 1 2023
Active Locations (2)
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1
Lutronic US Headquarters
Billerica, Massachusetts, United States, 01821
2
Union Square Dermatology
New York, New York, United States, 10003