Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Vulvovaginal Atrophy

  • STATUS
    Recruiting
  • days left to enroll
    62
  • participants needed
    30
  • sponsor
    InMode MD Ltd.
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Updated on 15 June 2022
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Accepts healthy volunteers

Summary

Prospective, one arm, baseline-controlled At least 30 healthy adult female volunteers, from 2 investigational sites seeking treatment for Symptoms of Vulvovaginal Atrophy Eligible subjects will receive 3 treatments 4 weeks apart with the MorpheusV Applicator according to the study protocol The subject will return for 3 follow up visits: 3 months follow up (3M FU), 6 months follow up (6M FU), 12months follow up (12M FU) after the treatment.

Total expected study duration is approximately 12 months.

Details
Condition Vaginal Atrophy
Treatment MorpheusV Applicator
Clinical Study IdentifierNCT05398172
SponsorInMode MD Ltd.
Last Modified on15 June 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Signed informed consent to participate in the study
BMI < 36
VHIS<15
Healthy non-smoking female subjects, > 35 and < 75 years of age at the time of enrolment post menopausal with absence of menstruation of at least 12 months
General good health confirmed by medical history and examination of the treated area
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 treatment methods in the treated area for the last 6 months and during the entire study period

Exclusion Criteria

Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance, unless deep enough in the periostal plane
Current or history of skin cancer, or current condition of any other type of cancer, or premalignant moles
Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases
Pregnancy and nursing
Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen
Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction
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
History of bleeding coagulopathies or use of anticoagulants in the last 10 days
Any surgery in treated area within 3 months prior to treatment
Simultaneous participation in another investigator drug or device study or completion of the follow-up phase for the primary endpoint of any previous study less than 30 days prior to the first evaluation in this study
Six months delay is required if other recent treatments like light, CO2 laser or RF were performed on the same area
Acute urinary tract infection (UTI), or genital infection (e.g. IVU, herpes genitalis, candida)
Treatment with any Vaginal Estrogen medication within 30 days
Prolapse beyond hymen
Any chronic condition that could interfere with study compliance
Use of Isotretinoin (Accutane®) within 6 months prior to treatment
As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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