Clinical trial NCT05398172: Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Vulvovaginal Atrophy
Official title: Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Vulvovaginal Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Atrophy
Lead sponsor: InMode MD Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-31
Enrollment: 30
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: effect of treatment on VVA symptoms,
timeFrame: baseline through 12 months
measure: objective evaluation of vaginal atrophy/estrogenization
timeFrame: baseline through 12 months
measure: Assess the effect of treatment on the general quality of life,
timeFrame: baseline through 12 months
measure: The effect of the treatment on Sexual Function
timeFrame: baseline through 12 months
measure: Assess the degree of difficulty encountered by the physician in performing the treatment,
timeFrame: baseline through 12 months
measure: The rate of satisfaction of patients with treatment
timeFrame: baseline through 12 months
measure: The effect of the treatment on urinary symptoms
timeFrame: baseline through 12 months
Secondary outcomes:
measure: Occurrence of expected post-treatment adverse events
timeFrame: up to 12 months
measure: Discomfort scale
timeFrame: up to 3 months
measure: Adverse events
timeFrame: baseline through 12 months
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Beyond Regenerative Medicine and Aesthetics
state: California
city: Knoxville
country: United States
facility: Institute for Female Pelvic Medicine
state: Tennessee
Study officials:
References: