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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04419454
Other study ID # DO609568A
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 5, 2020
Est. completion date July 30, 2022

Study information

Verified date May 2022
Source InMode MD Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite


Description:

The purpose of this preliminary report is to retrospectively evaluate this novel treatment approach to improve the appearance of cellulite on the thighs and buttocks by tightening the SFS using RFAL.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date July 30, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - age = 18years of age at the time of procedure - patients with localized lipodystrophy in the medial or lateral thigh, and visible cellulite of laxity in the lower extremity or buttocks - BodyTite treatments performed from January 2018 - May 2019 for Cellulite indication Exclusion Criteria: - active infection, collagen disorders, immunocompromised state, medications that mitigate inflammatory response, and propensity for keloid/hypertrophic scaring. o BodyTite treatments performed from March 2018 - May 2019 for lipodystrophy and cellulite of laxity

Study Design


Related Conditions & MeSH terms


Intervention

Device:
BodyTite
retrospectively evaluate this novel treatment approach to improve the appearance of cellulite on the thighs and buttocks by tightening the SFS using RFAL.

Locations

Country Name City State
United States Dr. Mark Peters Germantown Tennessee

Sponsors (1)

Lead Sponsor Collaborator
InMode MD Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Photonumeric Cellulite Severity Score Change in Photonumeric Cellulite Severity Score 3. Investigator assessment of the cellulite improvement comparing pre and post treatment using Global aesthetic improvement 5-point grading scale (0=No change, 1=1%-24%%, 2=25%-49%, 3=50%-74% improvement, and 4=75%-100%) at all follow up visits. [ Time Frame: Baseline to 6 months posttreatment]
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