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

Not Applicable

• Conditions: Vagina Atrophy
• Interventions: Device: NuEra Tight VRF Handpiece

• Registration Number: NCT04511260
• Lead Sponsor: Lumenis Be Ltd.

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.

Study Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-13
• Study Start: 2020-10-16
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08
• Primary Completion: 2021-06-20
• Study Completion: 2021-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VRF Treatment	NuEra Tight VRF Handpiece	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.

Primary Outcome Measures

Name	Time	Method
Safety and Efficacy of the NuEra small area handpiece	12 months	Evaluation of safety and short-term performance of the NuEra small area handpiece treatment on vaginal tissue laxity in pre- and post-menopausal women.; Change in vaginal laxity as measured by the subject reported laxity rating on a Vaginal Laxity Questionnaire (VLQ) 7-point scale at 1-month follow-up visit compared to baseline. Safety endpoints will include adverse events (AEs) and serious adverse events (SAEs) occurring at any time during the trial or follow-up.

Secondary Outcome Measures

Name	Time	Method
To evaluate the long-term effect on vaginal tissue laxity in pre- and post-menopausal women.	12 months	Change in vaginal laxity as measured by the subject reported laxity rating on a Vaginal Laxity Questionnaire (VLQ) 7-point scale at 3-months follow-up visit compared to baseline.
To evaluate overall improvement following the treatment.	12 months	(Optional) Improvement in visual appearance of the vaginal lips /genitals, self-assessed by women at 3 months follow up visit compared to baseline (optional- will be assessed in women receiving treatment for this purpose) - by B\&A photos
To evaluate the treatment effect on the general vaginal health.	12 months	Subject satisfaction with the treatment using a 5-point Likert scale from post first treatment and after the three months follow up visits by SSQ and Patient Global Impression of Improvement (PGI-I) determined as score of 1-3 (very much better-a little better).; Change in a physician-reported general vaginal health rating on a VHIS at 1 and 3 months follow up visits compared to baseline.
To evaluate the treatment effect on sexual function and overall satisfaction with sexual life	12 months	Change in sexual function as evaluated by the subject Female Sexual Function Index (FSFI) at 1, and 3 months follow up visits compared to baseline.
To evaluate procedure-related subject treatment pain and discomfort	12 months	Subject assessment of pain and discomfort that is procedure related using a visual a Pain Visual Analogue Scale (PVAS), evaluated at each treatment.
Secondary Objective - 3	12 months	To evaluate improvement in the appearance of the vulva and vaginal lips /genitals (optional)

Trial Locations

Locations (1)

NYDerm; 🇺🇸 New York, New York, United States