Recruiting

Hyivy Device

Sponsor:

Hyivy Health Inc

Code:

NCT05648253

Conditions

Vaginal Stenosis

Radiation Therapy

Cancer

Pelvic Pain

Pelvic Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hyivy Intravaginal Device

Study Details

Brief summary:

Vaginal dilator therapy (VDT) with static dilators is often prescribed to patients following vaginal or pelvic radiation therapy. This study seeks to evaluate the feasibility of a novel intravaginal device that delivers patient-controlled dilation (Hyivy device). The study is designed as a proof-of-concept single-arm pilot study. The primary objective is to assess safety and tolerability, while also evaluating changes in health-related quality of life and pelvic pain.

Conditions

Vaginal Stenosis

Radiation Therapy

Cancer

Pelvic Pain

Pelvic Cancer

Study ID

NCT05648253

Start date

Apr 11, 2025

Status verified date

Apr, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 1.Age ≥ 18 at the time of enrollment
  • 2.Patient with a vagina or vaginal canal who have completed radiation therapy (either external beam or brachytherapy, or a combination of both) for endometrial cancer, cervical cancer, anal cancer, or rectal cancer, without concomitant chemotherapy
  • 3.Generally in good health (other than due to cancer), at the discretion of the investigator(s)
  • 4.Eastern Cooperative Oncology Group (ECOG) score or 0 to 2
  • 5.Participants must be post-menopausal (natural or surgically) for at least 1 year prior to screening or be surgically sterile (absence of ovaries and/or uterus); or, a participant of child-bearing potential must agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months.
  • 6.Agree not to use other dilators for the 12-week intervention period
  • 7.Must have the ability to charge the investigational device
  • 8.Must be willing and able to insert intravaginal device
  • 9.Able to understand, comply and consent to protocol requirements and instructions
  • 10.Able to attend scheduled study visits and complete required investigations
  • 11.Ability to understand and willingness to sign written informed consent

Exclusion Criteria:

  • 1.Participants who are pregnant or planning to become pregnant during the trial
  • 2.Any major surgery in the past 3 months unless post-surgery dilator use is recommended by a physician, or anticipates having a major surgery during the study
  • 3.Any other medical condition or clinical finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational product or that may affect the interpretation of the results or leave the patient at high risk from treatment complications, at the discretion of the investigator(s)
  • 4.Allergy to Hyivy device's materials
  • 5.Active pelvic or gynaecological infection
  • 6.Current use of antibiotics for any infection
  • 7.Have open wounds, cuts, or open sores present in the vaginal or pelvic area
  • 8.Severe atrophic vaginitis or very dry, itchy, or sore vagina/vaginal area, at the discretion of the investigator(s)
  • 9.Hypoesthesia or loss in sensation of the pelvic floor
  • 10.Total and/or partial prolapse of the uterus and/or vagina
  • 11.Symptoms of severe urinary retention, severe extra-urethral incontinence, or overflow incontinence
  • 12.Unable to position the device according to directions for use
  • 13.Use of any medical devices that may interfere with the investigational device's function, such as pacemakers, ventilators, and ear implants

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hyivy Intravaginal Device

Participants will receive a Hyivy intravaginal device for at-home use. Recommended use is three times per week for 12 weeks and consists of 10 minutes of heat (37-39ºC) and 10 minutes of dilation per session.

Interventions

Hyivy Intravaginal Device

Intravaginal use of Hyivy device three times per week for 12 weeks, with each session consisting of 10 minutes of heat (37-39ºC) and 10 minutes of dilation.

Primary outcome measure

  • Safety and tolerability of the Hyivy device [ Time Frame: Up to 12-weeks ]

Central Contacts and Locations

Central contacts

Daniel Glick, MD

(519) 749-4370Daniel.Glick@grhosp.on.ca

Locations

Grand River Regional Cancer Centre, Waterloo Regional Health Network @ Midtown

Recruiting

Kitchener, Ontario, Canada, N2G 1G3

Contacts

Daniel Glick

519-749-4370Daniel.Glick@grhosp.on.ca

More Information

Sponsor

Hyivy Health Inc

Last update posted

Apr 22, 2025

Last verified

Apr, 2025

Keywords

  • Dilator
  • Post radiation therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hyivy Health Inc on 2025-04-22.