Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite

Cellulite Clinical Trial

Official title:

Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04419454
• Other study ID #: DO609568A
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cellulite

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]