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Feasibility of Hyivy Device Post-Radiation for Pelvic Malignancies

NCT05648253 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-04-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Grand River Hospital

    collaborator OTHER

  • Hyivy Health Inc

    lead INDUSTRY

Principal Investigators

  • Daniel Glick, MD · Grand River Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-11
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05648253 on ClinicalTrials.gov