NCT04419454

Brief Summary

Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

August 12, 2022

Status Verified

May 1, 2022

Enrollment Period

2.2 years

First QC Date

June 3, 2020

Last Update Submit

August 10, 2022

Conditions

Cellulite

Outcome Measures

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: Baseline to 6 months posttreatment]

Interventions

BodyTiteDEVICE

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

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Mark Peters

Germantown, Tennessee, 38138, United States

Location

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mark Petrs, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 5, 2020

Study Start

May 5, 2020

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

August 12, 2022

Record last verified: 2022-05

Locations

US(1)