Evaluation of the Safety and Efficacy of the NuEra Tight VRF for the Treatment of Vaginal and Vulvar Tissue Laxity

Lumenis

Status: Unknown

Conditions: Vagina Atrophy

Treatments: Device: NuEra Tight VRF Handpiece

Study type: Interventional

Funder types: Industry

Identifiers

NCT04511260

LUM-ABU- NuEra VRF 20-01

Details and patient eligibility

About

Up to twenty (20) healthy pre- and post-menopausal women with self-reported vaginal laxity will be enrolled in the study.

Full description

The treatment will include: A treatment of the vaginal canal using the NuEra Tight VRF small area handpiece. A treatment of the introitus and vestibule using the NuEra Tight VRF small area hand piece (optional).

This is a single center, prospective, open label, single arm study. Following screening visit, eligible subjects will be enrolled into the study. Each subject will receive 3 treatments, 4 weeks apart and 2 Follow Up (FU) visits, at 1, and 3 months following the last treatment.

Enrollment: 20 estimated patients

Sex: Female

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women age between 35 to 60
• Last vaginal delivery is at least 12 months prior to enrollment
• Self-reported vaginal laxity defined as "very loose," "moderately loose," or "slightly loose" on the Vaginal Laxity Questionnaire (VLQ)
• Sexual activity≥ once per month, with a same partner
• Willing to use contraception for the duration of the study
• Negative urine analysis
• Negative pregnancy test
• Patient is not pregnant nor planning to become pregnant throughout the duration of the study
• Willing to improve vaginal lips / genitals appearance (optional)
• Normal gynecological exam from the recent year
• If taking probiotics and/or any other supplement or suppository as part of daily regimen, willing to maintain same regimen throughout the entire duration of the study
• Able and willing to comply with the treatment/follow-up schedule and requirements ·
• Willing to sign an informed consent

Exclusion criteria

• Previous pelvic floor reconstructive surgery with mesh.
• Pelvic organ prolapse (POP) >II according to the pelvic organ prolapse quantification system
• Pregnant or lactating
• Women in post-menopausal stage for more than five years.
• Active genital infection or sexually transmitted diseases
• Subject presenting abnormal Pap smear result from the last five years with any of the following findings according to the Bethesda System (2001) classification: A.. Atypical Squamous Cells-cannot exclude high grade squamous intraepithelial lesion B. Atypical Glandular Cells (Endocervical, Endometrial not otherwise specified) C. High Grade squamous intraepithelial lesion (HSIL)D. Carcinoma
• Patients with implantable devices, such as but not limited to pacemakers, implanted defibrillators, and Cochlear ear implant
• Serious systemic disease or any chronic condition that could interfere with study compliance
• Has metal implant(s) within the treated area, such as surgical clips, plates and screws, intrauterine device (IUD) or artificial joints
• History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
• History of vaginal tissue disease in the treatment area
• Taken part in a clinical trial involving an investigational drug or device within 30 days prior to screening and through the study duration
• Presence of Vulvar lesions or any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety
• Nerve insensitivity to heat anywhere in the treatment area, since ongoing feedback by a patient during a procedure is required
• Previous treatment with a vaginal energy based device, including laser treatment.
• Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

VRF Treatment

Experimental group

Description:

A treatment of the vaginal canal using the NuEra Tight VRF small area handpiece. A treatment of the introitus and vestibule using the NuEra Tight VRF small area hand piece (optional). Following screening visit, eligible subjects will be enrolled into the study. Each subject will receive 3 treatments, 4 weeks apart and 2 Follow Up (FU) visits, at 1, and 3 months following the last treatment.

Treatment:

Device: NuEra Tight VRF Handpiece