ClinicalTrials.gg
CompletedNCT04419454Updated Aug 12, 2022

Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite

An observational study in Cellulite, sponsored by InMode MD Ltd.. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-12.

Sponsored by InMode MD Ltd. (part of InMode Ltd.) · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10
Ages
18 Years and older
Sex
Female
01

Study summary

Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite

Read the detailed 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.

02

Conditions studied

  • Cellulite

Browse trials for

03

In context

Cellulite

71 studies on the registry are indexed under Cellulite; 3 are open to participants now.

Browse Cellulite studies →

Lead sponsor

InMode MD Ltd. is the lead sponsor of 25 studies on the registry; 5 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 8 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Sample size will be a result of available charts from a 16-month retrospective review January 2018 - May 2019. The sample will not include any vulnerable populations (pregnant women, minors, or prisoners)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • active infection, collagen disorders, 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10 participants (actual)
Patient registry
No

Interventions

  • DeviceBodyTite

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

06

What researchers measure

Primary outcomes

  1. 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: [ Time Frame: Baseline to 6 months posttreatment]

07

Study locations

1 site
  • Dr. Mark Peters
    Germantown, Tennessee 38138, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04419454
Lead sponsor
InMode MD Ltd.
Responsible party
Sponsor
First posted
Jun 5, 2020
Start date
May 5, 2020
Primary completion
Jul 30, 2022
Completion
Jul 30, 2022
Last update
Aug 12, 2022

Study contacts

Mark Petrs, MD
principal investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion