Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID05648253

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

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

12

Participants Needed

1

Research Sites

N/A

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

This research aims to evaluate a new vaginal dilator device called the Hyivy device in women who have undergone vaginal or pelvic radiation therapy for pelvic cancers such as endometrial, cervical, anal, or rectal cancer. The study focuses on assessing the safety and tolerability of this novel device while also examining its effects on health-related quality of life and pelvic pain. Vaginal stenosis, a narrowing or shortening of the vaginal canal caused by radiation, can lead to discomfort and tissue damage, and current treatments often have low adherence. Participants will use the Hyivy intravaginal device at home three times a week for 12 weeks. Each session includes 10 minutes of gentle heat between 37 and 39 degrees Celsius followed by 10 minutes of dilation. Participants are instructed not to use other dilators during the intervention period. The study is designed as a single-arm pilot to explore the feasibility and patient experience with this patient-controlled device. Throughout the study, participants will attend scheduled visits for assessments including safety and tolerability monitoring, quality of life questionnaires, and pelvic pain evaluations at baseline, 6 weeks, and 12 weeks. Adherence to the treatment protocol will also be tracked. The total intervention period is 12 weeks, and participants must be able to comply with device use and follow-up requirements. The researchers will review safety data and patient-reported outcomes to understand the device's impact and usability.

CONDITIONS

Brief 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 enrollment
  • Female patients with a vagina or vaginal canal who have completed vaginal or pelvic radiation therapy for endometrial, cervical, anal, or rectal cancer without chemotherapy
  • Generally in good health aside from cancer, as judged by investigators
  • Eastern Cooperative Oncology Group (ECOG) score between 0 and 2
  • Post-menopausal for at least 1 year or surgically sterile, or using medically approved birth control if of child-bearing potential with hormonal birth control used for at least 3 months
  • Agree not to use other vaginal dilators during the 12-week intervention
  • Able to charge the investigational device
  • Willing and able to insert the intravaginal device
  • Able to understand and comply with study protocol and attend scheduled visits
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or planning to become pregnant during the trial
  • Major surgery within the past 3 months unless dilator use is recommended post-surgery, or planning major surgery during the study
  • Any medical condition that contraindicates device use or may affect study results, as judged by investigators
  • Allergy to materials in the Hyivy device
  • 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, as judged by investigators
  • Loss of pelvic floor sensation
  • Total or partial prolapse of uterus or vagina
  • Severe urinary retention or incontinence symptoms
  • Unable to position the device as directed
  • Use of medical devices that interfere with the investigational device such as pacemakers, ventilators, or ear implants

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants use the Hyivy intravaginal device at home, applying heat and dilation three times per week to prevent vaginal stenosis after pelvic radiation therapy.

Regular at-home use three times per week for 12 weeks

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

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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Published Research Related To This Trial

Vaginal Dilator and Pelvic Floor Exercises for Vaginal Stenosis, Sexual Health and Quality of Life among Cervical Cancer Patients Treated with Radiation: Clinical Report.

Paulina Araya-Castro, Cinara Sacomori, Paulette Diaz-Guerrero...

https://pubmed.ncbi.nlm.nih.gov/32364016