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RECRUITING
NCT05648253
NA

Feasibility of Hyivy Device Post-Radiation for Pelvic Malignancies

Sponsor: Hyivy Health Inc

View on ClinicalTrials.gov

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.

Official title: Pilot Study to Assess the Feasibility of Use of a Novel Vaginal Dilator Device Post-radiation for Patients With Pelvic Malignancies

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2025-04-11

Completion Date

2026-06

Last Updated

2025-04-22

Healthy Volunteers

No

Interventions

DEVICE

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.

Locations (1)

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

Kitchener, Ontario, Canada