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

Primary Purpose

Vagina Atrophy

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NuEra Tight VRF Handpiece
Sponsored by
Lumenis Be Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vagina Atrophy

Eligibility Criteria

35 Years - 60 Years (Adult)FemaleAccepts 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

Sites / Locations

  • NYDermRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VRF Treatment

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Secondary Objective - 3
To evaluate improvement in the appearance of the vulva and vaginal lips /genitals (optional)
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
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.
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.

Full Information

First Posted
August 5, 2020
Last Updated
December 6, 2020
Sponsor
Lumenis Be Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04511260
Brief Title
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2020 (Actual)
Primary Completion Date
June 20, 2021 (Anticipated)
Study Completion Date
June 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumenis Be Ltd.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vagina Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VRF Treatment
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
NuEra Tight VRF Handpiece
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety and Efficacy of the NuEra small area handpiece
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
To evaluate the long-term effect on vaginal tissue laxity in pre- and post-menopausal women.
Description
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.
Time Frame
12 months
Title
To evaluate the treatment effect on sexual function and overall satisfaction with sexual life
Description
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.
Time Frame
12 months
Title
Secondary Objective - 3
Description
To evaluate improvement in the appearance of the vulva and vaginal lips /genitals (optional)
Time Frame
12 months
Title
To evaluate overall improvement following the treatment.
Description
(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
Time Frame
12 months
Title
To evaluate the treatment effect on the general vaginal health.
Description
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.
Time Frame
12 months
Title
To evaluate procedure-related subject treatment pain and discomfort
Description
Subject assessment of pain and discomfort that is procedure related using a visual a Pain Visual Analogue Scale (PVAS), evaluated at each treatment.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gally Glass, M.Sc.
Phone
+972.4.9099.455
Email
gally.glass@lumenis.com
Facility Information:
Facility Name
NYDerm
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NYDerm
Phone
212-570-2067
Email
email@nyderm.org
First Name & Middle Initial & Last Name & Degree
Macrene Alexiades, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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