Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05648253

Feasibility of Hyivy Device Post-Radiation for Pelvic Malignancies

Led by Hyivy Health Inc · Updated on 2025-04-22

12

Participants Needed

1

Research Sites

59 weeks

Total Duration

On this page

Sponsors

H

Hyivy Health Inc

Lead Sponsor

G

Grand River Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Feasibility of Hyivy Device Post-Radiation for Pelvic Malignancies

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at the time of enrollment
  • Have a vagina or vaginal canal and completed radiation therapy (external beam or brachytherapy) for endometrial, cervical, anal, or rectal cancer without chemotherapy
  • Generally in good health apart from cancer, as determined by the investigator
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
  • Post-menopausal for at least 1 year or surgically sterile, or child-bearing potential participants must use approved birth control during the study, with hormonal birth control used for at least 3 months
  • Agree not to use other vaginal dilators during the 12-week intervention
  • Ability to charge the investigational device
  • Willing and able to insert the intravaginal device
  • Able to understand, comply with, and consent to study requirements
  • Able to attend scheduled visits and complete required tests
  • Willing and able to sign written informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or planning pregnancy during the trial
  • Major surgery in past 3 months unless post-surgery dilator use is recommended or planned major surgery during the study
  • Any medical condition or finding that contraindicates device use or may affect results, as judged by investigator
  • Allergy to Hyivy device materials
  • Active pelvic or gynecological infection
  • Current antibiotic use for infection
  • Open wounds, cuts, or sores in vaginal or pelvic area
  • Severe atrophic vaginitis or very dry, itchy, or sore vaginal area, per investigator discretion
  • Loss of pelvic floor sensation (hypoesthesia)
  • Total or partial prolapse of uterus or vagina
  • Severe urinary retention, severe extra-urethral incontinence, or overflow incontinence
  • Unable to position the device properly
  • Use of medical devices that could interfere with the investigational device, like pacemakers, ventilators, or ear implants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Kitchener, Ontario, Canada, N2G 1G3

Actively Recruiting

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Research Team

D

Daniel Glick, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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