An interventional study of Evoke Device in Improvement of Skin Appearance, sponsored by InMode MD Ltd.. Completed at 3 sites in United States. Open to participants aged 35 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by InMode MD Ltd. (part of InMode Ltd.) · Not applicable, Interventional, and Treatment
The aim of the study is to evaluate the safety, efficacy, patient comfort and patient satisfaction after Evoke treatment
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments (Tx.1, Tx.2 and Tx.3).
Device: Evoke Device
Subjects will undergo treatment with Evoke Device
Number of participants with Change in Skin Appearance
Picture evaluation by blinded investigators.
Time frame: 1 month, 3 month, 6 months
Evaluate rate of Change in Skin Appearance using 3D Photographic analysis
3D Photographic analysis will be conducted using QuantifiCare System
Time frame: 1 month, 3 month, 6 months
Evaluate changes in skin using VivoSight Optical Coherence Tomography (OCT) software
Non-invasive in vivo skin imaging will be taken with the VivoSight Optical Coherence Tomography (OCT).
Time frame: 1 month, 3 month, 6 months
Evaluate changes in skin appearance comparing photographs using Mechanical Turk (MTurk). The pictures will be sent through the system and evaluated by crowd workers.
The pictures will be sent through the system and evaluated by crowd workers.
Time frame: 1 month, 3 month, 6 months
Evaluate Investigator assessment of the skin appearance improvement
Investigator assessment of the skin appearance improvement comparing pre and post treatment using 0 - 4 -points Likert scale at 1 month, 3 months and 6 months follow up visits: • 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference
Time frame: 1 Month, 3 Months, 6 Months
Evaluate Subject assessment of improvement and satisfaction
Improvement assessment will be performed independently by the subject himself 4 points Likert scale questionnaire (Global Aesthetic Improvement Scale), as follows: • 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference. Subject assessment of satisfaction will be filled out by subjects using a 5-points Likert scale, as follows: • +2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Very disappointed.
Time frame: 1 Month, 3 Months, 6 Months
Evaluate histological changes to treatment area skin
Positive changes in histologic evaluation: up to 5 subjects will undergo biopsies of the treated area for histology at baseline and at 3M follow-up visit. Histological sections will be stained using elastin, H\&E and other collagen specific stains.
Time frame: 3 Months
Ran from Jun 2019 to primary completion in Dec 2021, 30 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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