Recruiting

NuEra Tight

Sponsor:

Lumenis Be Ltd.

Code:

NCT04511260

Conditions

Vagina Atrophy

Eligibility Criteria

Sex: Female

Age: 35 - 60

Healthy Volunteers: Accepted

Interventions

NuEra Tight VRF Handpiece

Study Details

Brief summary:

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

Conditions

Vagina Atrophy

Study ID

NCT04511260

Start date

Oct 16, 2020

Status verified date

Dec, 2020

Completion date

Jun 20, 2021

Anticipated

Primary completion date

Jun 20, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35 - 60

Healthy Volunteers: Accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Safety and Efficacy of the NuEra small area handpiece [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Gally Glass, M.Sc.

+972.4.9099.455gally.glass@lumenis.com

Locations

NYDerm

Recruiting

New York, New York, United States, 10028

Contacts

NYDerm

212-570-2067email@nyderm.org

Principal Investigator:

Macrene Alexiades, MD

More Information

Sponsor

Lumenis Be Ltd.

Last update posted

Dec 8, 2020

Last verified

Dec, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lumenis Be Ltd. on 2020-12-08.