Clinical Trials Logo
  1. Home
  2. Cellulite
  3. NCT04419454
  4. Details
NCT04419454 Clinical Trial

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
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]
See also
  Status Clinical Trial Phase
Completed NCT03550157 - Structural Changes of Subcutaneous Tissue by Ultrasonographies in Patients After Treatment With PnKCelulitis® Program
Completed NCT03078647 - Profound Dermal and SubQ Cartridges for the Treatment of Cellulite N/A
Suspended NCT05441917 - Phototherapy and Radiofrecuency for Cellulite N/A
Completed NCT02942160 - EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite) Phase 2
Active, not recruiting NCT02489994 - Performance of the ePrime System for Cellulite N/A
Completed NCT01209767 - Cryolipolysis and Subcision for Treatment of Cellulite N/A
Completed NCT01702259 - Study of the Effect of Low Level Laser Light Therapy on Reducing the Appearance of Cellulite in the Thighs and Buttocks. N/A
Completed NCT04580303 - CCH Treatment of Cellulite in the Presence of Dermal Laxity With Comparison Between Two (2) Different Injection Techniques Phase 2
Completed NCT05358847 - Treatment for Cellulite Appearance N/A
Terminated NCT04209530 - Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Women Phase 2
Completed NCT05064761 - Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite N/A
Completed NCT03329989 - Safety and Effectiveness of EN3835 in the Treatment of EFP in Women Phase 2
Completed NCT04170296 - Real World CCH Study in Adult Females With Cellulite Phase 3
Completed NCT05199506 - Study to Evaluate the Safety and Effectiveness of the RAP Device for the Improvement in the Appearance of Cellulite N/A
Active, not recruiting NCT05836779 - A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 2) Phase 2
Completed NCT05026216 - To Assess the Effectiveness of Multiple Dose, Multiple Concentrations of Qwo, for the Treatment of Mild to Moderate Cellulite. Phase 4
Completed NCT00399854 - Evaluation of the Efficacy of Endermologie in Treatment of Cellulite and Body Contouring Phase 4
Completed NCT00947414 - Cellulite and Extracorporeal Shock Wave N/A
Completed NCT05419505 - Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks Phase 2
Completed NCT03981198 - Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite N/A