CelluliteNCT04419454
Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite
An observational study of Cellulite, run by InMode MD Ltd. at 1 site in United States.
Trial summary
Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulite
- What is being tested?
- BodyTite
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2020to 30 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cellulite
- Being tested
- BodyTite
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BodyTiteDevice
retrospectively evaluate this novel treatment approach to improve the appearance of cellulite on the thighs and buttocks by tightening the SFS using RFAL.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [ Time Frame: Baseline to 6 months posttreatment]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start5 May 2020
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CelluliteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Petrs, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419454
- Sponsor's protocol ID
- DO609568A
- Status last verified
- May 2022
- First submitted
- 3 Jun 2020
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite
- ClinicalTrials.gov ID
- NCT04419454
- Acronym / sponsor ID
- DO609568A
- Conditions
- Cellulite
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 May 2020 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- age ≥ 18years of age at the time of procedure
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BodyTiteretrospectively evaluate this novel treatment approach to improve the appearance of cellulite on the thighs and buttocks by tightening the SFS using RFAL. | Device | – |
Primary outcome
Photonumeric Cellulite Severity Score
Time frame: [ Time Frame: Baseline to 6 months posttreatment]
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Petrs, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cellulite, run by InMode MD Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photonumeric Cellulite Severity Score (time frame: [ Time Frame: Baseline to 6 months posttreatment]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.