Cellulite of ThighsNCT03769649
Clinical Evaluation of CelluTite Treatment
A study testing CelluTite in people with Cellulite of Thighs, run by InMode MD Ltd. at 1 site in United States.
Trial summary
This prospective study is intended to evaluate the CelluTite RFAL handpiece combined with Morpheus8 handpiece for the treatment of cellulite. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulite of Thighs
- What is being tested?
- CelluTite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2018to 17 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female subjects aged 18-70 having mild/moderate grade cellulites.
- The patients should understand the information provided about the treatment, possible benefits and side effects, and sign the Informed Consent Form, (including the permission to use photography).
- The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods in the treatment area for the last 6 months and during the entire study period.
Who cannot join
- Body fat layer thinner than 5mm.
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- Superficial permanent implant in the treated area such as metal plates and screws, metal piercing, silicone implants or an injected chemical substance.
- Current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles.
- Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
- Pregnancy and nursing.
Show all 16Show fewer
- History of bleeding coagulopathies or use of anticoagulants.
- Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
- Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.
- Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
- Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
- Any surgery or treatment such as laser or chemicals in treated area within 3-6 months prior to treatment or before complete healing.
- Allergies, in particular to anesthesia.
- Mental disorders such as Body Dysmorphic Disorder (BDD).
- As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Safety and Efficacy of the CelluTite Treatment
This prospective study is intended to evaluate the CelluTite RFAL handpiece combined with Morpheus8 handpiece for the treatment of cellulite.
Read the detailed description
The study will evaluate the safety and efficacy of cellulite treatment using two hand pieces:
- The CelluTite - based on a minimally invasive, temperature-controlled Radiofrequency-assisted lipolysis (RFAL) technology. RF energy is applied using a handpiece with 2 electrodes: internal active electrode with spatula-shaped tip and external electrode.
- The Morpheus8 - designed to deliver RF energy to the skin surface in a fractional manner via an array of 24-electrode pins.
- Conditions
- Cellulite of Thighs
- Being tested
- CelluTite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelluTiteDevice
Also called Morpheus8
CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Subjects receive CelluTite treatment followed by Morpheus8 treatment Receives: Device: CelluTite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
Photos from 6 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome
Measured: 6 months
Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.
Measured: 6 months
Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
Photos from 6 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome
Measured: 6 months
Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
Photos from 1month follow-up visits will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS).
Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome
Measured: 1 month
Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
Photos from 3 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome
Measured: 3 months
Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
Photos 1 month follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome
Measured: 1 month
Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
Photos 3 month follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome
Measured: 3 months
Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
Photos 1 week follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome
Measured: 1 week
Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
Photos from 1 week ollow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome
Measured: 1 week
Assessment of Adverse Events Occurrence Based on Severity
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
Measured: 3 months
Assessment of Adverse Events Occurrence Based on Severity
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
Measured: 1 month
Assessment of Adverse Events Occurrence Based on Severity
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
Measured: 1 week
Assessment of Adverse Events Occurrence Based on Severity
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
Measured: Treatment Day
Assessment of Adverse Events Occurrence Based on Severity
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
Measured: 6 Months
Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.
Measured: 3 months
Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.
Measured: 1 week
Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.
Measured: Treatment Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start12 Nov 2018
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cellulite of ThighsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will receive the treatment and outcome will be followed
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Katz, MD, Principal investigator, 60 E 56th St #2, New York, NY 10022, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769649
- Sponsor's protocol ID
- DO608110
- Status last verified
- Sep 2019
- First submitted
- 4 Dec 2018
- Last updated
- 8 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Safety and Efficacy of the CelluTite Treatment
- ClinicalTrials.gov ID
- NCT03769649
- Acronym / sponsor ID
- DO608110
- Conditions
- Cellulite of Thighs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Posted 16 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective study is intended to evaluate the CelluTite RFAL handpiece combined with Morpheus8 handpiece for the treatment of cellulite.
Detailed description
The study will evaluate the safety and efficacy of cellulite treatment using two hand pieces:
- The CelluTite - based on a minimally invasive, temperature-controlled Radiofrequency-assisted lipolysis (RFAL) technology. RF energy is applied using a handpiece with 2 electrodes: internal active electrode with spatula-shaped tip and external electrode.
- The Morpheus8 - designed to deliver RF energy to the skin surface in a fractional manner via an array of 24-electrode pins.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will receive the treatment and outcome will be followed
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: CelluTiteSubjects receive CelluTite treatment followed by Morpheus8 treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female subjects aged 18-70 having mild/moderate grade cellulites.
- The patients should understand the information provided about the treatment, possible benefits and side effects, and sign the Informed Consent Form, (including the permission to use photography).
- The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods in the treatment area for the last 6 months and during the entire study period.
Key exclusion criteria (16 listed)
- Body fat layer thinner than 5mm.
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- Superficial permanent implant in the treated area such as metal plates and screws, metal piercing, silicone implants or an injected chemical substance.
- Current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles.
- Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
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 |
|---|---|---|
| CelluTiteAlso: Morpheus8CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF | Device | Treatment arm |
Primary outcome
Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
Time frame: 6 months
Photos from 6 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome
Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
Time frame: 6 months
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.
Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
Time frame: 6 months
Photos from 6 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome
Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
Time frame: 1 month
Photos from 1month follow-up visits will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome
Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
Time frame: 3 months
Photos from 3 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome
Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
Time frame: 1 month
Photos 1 month follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome
Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
Time frame: 3 months
Photos 3 month follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome
Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
Time frame: 1 week
Photos 1 week follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome
Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
Time frame: 1 week
Photos from 1 week ollow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome
Assessment of Adverse Events Occurrence Based on Severity
Time frame: 3 months
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
Assessment of Adverse Events Occurrence Based on Severity
Time frame: 1 month
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
Assessment of Adverse Events Occurrence Based on Severity
Time frame: 1 week
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
Assessment of Adverse Events Occurrence Based on Severity
Time frame: Treatment Day
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
Assessment of Adverse Events Occurrence Based on Severity
Time frame: 6 Months
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
Time frame: 3 months
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.
Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
Time frame: 1 week
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.
Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
Time frame: Treatment Day
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Thigh Cellulite
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.
Bruce Katz, MD principal investigator
60 E 56th St #2, New York, NY 10022, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CelluTite in people with Cellulite of Thighs, 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 16 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 8 Jun 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?
Yes. Results are posted in the registry (first posted 16 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples) (time frame: 6 months). The study lists 17 primary outcomes in all. 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 8 Jun 2022.