An interventional study of CelluTite in Cellulite of Thighs, sponsored by InMode MD Ltd.. Completed at 1 site in United States. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-08.
Sponsored by InMode MD Ltd. (part of InMode Ltd.) · Not applicable, Interventional, and Treatment
This prospective study is intended to evaluate the CelluTite RFAL handpiece combined with Morpheus8 handpiece for the treatment of cellulite.
The study will evaluate the safety and efficacy of cellulite treatment using two hand pieces:
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 15 is below the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →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.
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.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects receive CelluTite treatment followed by Morpheus8 treatment
Device: CelluTite
CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Also known as: Morpheus8
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Treatment Day
| Milestone | Treatment Arm |
|---|---|
| Started | 15 |
| Completed | 11 |
| Not completed | 4 |
| Withdrew: Lost to follow-up | 4 |
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
| score on a scale | Treatment Arm |
|---|---|
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples) | 2.45 ± 1.04 |
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.
| score | Treatment Arm |
|---|---|
| Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment) | 0 ± 0 |
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
| score on a scale | Treatment Arm |
|---|---|
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour) | 2.64 ± 0.92 |
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
| score on a scale | Treatment Arm |
|---|---|
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour) | 2.89 ± 0.93 |
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
| score on a scale | Treatment Arm |
|---|---|
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour) | 2.82 ± 0.87 |
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
| score on a scale | Treatment Arm |
|---|---|
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples) | 2.6 ± 1.07 |
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
| score on a scale | Treatment Arm |
|---|---|
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples) | 2.64 ± 0.81 |
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
| score on a scale | Treatment Arm |
|---|---|
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples) | 1.9 ± 0.99 |
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
| score on a scale | Treatment Arm |
|---|---|
| Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour) | 2 ± 0.82 |
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).
| score | Treatment Arm |
|---|---|
| Assessment of Adverse Events Occurrence Based on Severity | 0 ± 0 |
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).
| score on a scale | Treatment Arm |
|---|---|
| Assessment of Adverse Events Occurrence Based on Severity | 0 ± 0 |
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).
| score on a scale | Treatment Arm |
|---|---|
| Assessment of Adverse Events Occurrence Based on Severity | 0.08 ± 0.27 |
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).
| score on a scale | Treatment Arm |
|---|---|
| Assessment of Adverse Events Occurrence Based on Severity | 0.2 ± 0.41 |
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.
| score | Treatment Arm |
|---|---|
| Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment) | 0 ± 0 |
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).
| score on a scale | Treatment Arm |
|---|---|
| Assessment of Adverse Events Occurrence Based on Severity | 0 ± 0 |
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.
| score | Treatment Arm |
|---|---|
| Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment) | 0 ± 0 |
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.
| score | Treatment Arm |
|---|---|
| Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment) | 0.16 ± 0.55 |
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.
| score | Treatment Arm |
|---|---|
| Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment) | 0.4 ± 0.8 |
Collected over Adverse event data was collected over a period of 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Arm | 0/15 (0%) | 0/15 (0%) | 4/15 (26.7%) |
| Event | Treatment Arm |
|---|---|
| PainSurgical and medical procedures | 4/15 |
Only subjects that finished all visits were analyzed
| Age, Continuous(years) | Treatment Arm |
|---|---|
| Mean | 50.62 ± 8.83 |
| Sex: Female, Male(Participants) | Treatment Arm |
|---|---|
| Female | 11 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Treatment Arm |
|---|---|
| White Non-Hispanic | 7 |
| Hispanic or Latino | 3 |
| Biracial | 1 |
| Cellulite Score Rated According to Cellulite Severity Scale (Dimples)(score on a scale) | Treatment Arm |
|---|---|
| Mean | 3.45 ± 0.69 |
| Cellulite Score Rated According to Cellulite Severity Scale (Contour)(score on a scale) | Treatment Arm |
|---|---|
| Mean | 3.55 ± 0.69 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2018 to primary completion in Jan 2020, 14 months.
Results were first posted in Feb 2021, 1 year after primary completion.
Of 20 interventional studies with no phase under Cellulite, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 14 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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