Clinical trial NCT04511260: Evaluation of the Safety and Efficacy of the NuEra Tight VRF for the Treatment of Vaginal and Vulvar Tissue Laxity
Official title: Evaluation of the Safety and Efficacy of the NuEra Tight VRF for the Treatment of Vaginal and Vulvar Tissue Laxity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vagina Atrophy
Lead sponsor: Lumenis Be Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-13
Enrollment: 20
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The NuEra device family is FDA cleared (K151296) for a wide range of indications including, but not limited to, selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The NuEra Tight - model VRF with the small area handpiece is CE marked in Europe and currently under review by the FDA. In this study, the Radio Frequency treatment will be administered in a continuous motion to the vaginal mucosa and the introitus using the small area handpiece.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and Efficacy of the NuEra small area handpiece
timeFrame: 12 months
Secondary outcomes:
measure: To evaluate the long-term effect on vaginal tissue laxity in pre- and post-menopausal women.
timeFrame: 12 months
measure: To evaluate the treatment effect on sexual function and overall satisfaction with sexual life
timeFrame: 12 months
measure: Secondary Objective - 3
timeFrame: 12 months
measure: To evaluate overall improvement following the treatment.
timeFrame: 12 months
measure: To evaluate the treatment effect on the general vaginal health.
timeFrame: 12 months
measure: To evaluate procedure-related subject treatment pain and discomfort
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYDerm
state: New York
Study officials:
References: