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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | All subjects enrolled in the study will be placed into the treatment arm of the study, to be treated by the Accufit device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accufit | Device | Magnet-based and Direct muscle stimulation devices are commonly used to generate current flow through the muscles in order to activate the muscle. The Accufit Electrical Muscle Stimulation device is an FDA cleared device having a two-channel stimulator that provides up to 8 electrodes with waveforms of interferential and biphasic for muscle stimulation. The Accufit system is indicated for relaxation of muscles, muscle re-education, reduction of pain and increased local blood circulation. Muscle stimulation technology has been around for many decades and has been shown to be safe and effective for a variety of clinical applications. The foundational basis for the technology revolves around electrical current flowing through the muscle can be used to activate the muscle. |
| Measure | Description | Time Frame |
|---|---|---|
| Photographic Evaluation | Photographic evaluation by an independent, blinded reviewer with correct identification of pre-treatment baseline images when compared to post-treatment images taken at follow up visits (48 hours, 30 days, 90 days).Results will be reported as a % of the correctly identified post treatment photographs chosen per Blinded Reviewer. An average of the % of the correctly identified post treatment photographs chosen by Blinded Reviewer will be calculated and used to determine efficacy. | Baseline, 48-hours post treatment, 30-day FU, 90-day FU |
| Measure | Description | Time Frame |
|---|---|---|
| Circumferential Reduction | Reduction in circumference as measured by Seca Circumferential System at follow up visits compared to baseline measurement. Measurements were taken of the right and left arm in both a relaxed and engaged position. | Baseline, 30-day FU, 90-day FU |
| Subject Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lutronic US Headquarters | Billerica | Massachusetts | 01821 | United States | ||
| Union Square Dermatology |
No IPD Sharing planned at this time.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 8, 2021 | Nov 22, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005218 | Fat Necrosis |
| ID | Term |
|---|---|
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Assess subject satisfaction using Satisfaction survey at each follow up visit. Scores available in the scale include the following:
|
| 30-day FU, 90-day FU |
| Global Aesthetic Improvement Scale | A scale to assess the overall improvement in a subject's condition in an unblinded fashion. Choices on the scale include the following:
| 30-day FU, 90-day FU |
| Muscle Strength | Improvement in muscle strength of the treated extremity as measured by a dynamometer at follow up visits compared to baseline measurements. Subjects are asked to hold onto a handheld device which will then be used to measure the strength of the bicep and tricep muscles. | Baseline, 30-day FU, 90-day FU |
| New York |
| New York |
| 10003 |
| United States |