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

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

Study Overview

• Status: Unknown
• Conditions: Vagina Atrophy
• Intervention / Treatment: Device: NuEra Tight VRF Handpiece

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gally Glass, M.Sc.; Phone Number: +972.4.9099.455; Email: gally.glass@lumenis.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10028
      • Recruiting
      • NYDerm
      • Contact: NYDerm; Phone Number: 212-570-2067; Email: email@nyderm.org
      • Principal Investigator: Macrene Alexiades, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: VRF Treatment; 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.

Device: NuEra Tight VRF Handpiece; The VRF is a Model that belongs to the NuEra Tight RF Family, specific for the treatment of small areas. The NuEra 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 VRF with the small area handpiece is CE marked in Europe and currently under review by the FDA. The system and its accessories, are intended to be use for a wide range of indications including, but not limited to: · Provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation of soft tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Efficacy of the NuEra small area handpiece	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the long-term effect 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 3-months follow-up visit compared to baseline.	12 months
To evaluate the treatment effect on sexual function and overall satisfaction with sexual life	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.	12 months
Secondary Objective - 3	To evaluate improvement in the appearance of the vulva and vaginal lips /genitals (optional)	12 months
To evaluate overall improvement following the treatment.	(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	12 months
To evaluate the treatment effect on the general vaginal health.	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.	12 months
To evaluate procedure-related subject treatment pain and discomfort	Subject assessment of pain and discomfort that is procedure related using a visual a Pain Visual Analogue Scale (PVAS), evaluated at each treatment.	12 months

Collaborators and Investigators

• Sponsor: Lumenis Be Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Anticipated): June 20, 2021
• Study Completion (Anticipated): June 20, 2021

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 6, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: LUM-ABU- NuEra VRF 20-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No