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

InMode

Status

Completed

Conditions

Vaginal Atrophy

Treatments

Device: MorpheusV Applicator

Study type

Interventional

Funder types

Industry

Identifiers

NCT05398172

DO610363A

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Female

Ages

35 to 75 years old

Volunteers

Accepts Healthy Volunteers

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