Evaluating a new device for vaginal dilation after pelvic radiation therapy
Pilot Study to Assess the Feasibility of Use of a Novel Vaginal Dilator Device Post-radiation for Patients With Pelvic Malignancies
This study is testing a new device that helps women who have had pelvic radiation therapy to safely and comfortably manage vaginal dilation and see if it improves their quality of life and reduces pelvic pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hyivy Health Inc Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Kitchener, Ontario) |
| Trial ID | NCT05648253 on ClinicalTrials.gov |
What this trial studies
This study assesses the feasibility of the Hyivy device, a novel intravaginal device designed for patient-controlled dilation, in patients who have undergone radiation therapy for pelvic malignancies. It aims to evaluate the safety and tolerability of the device while measuring changes in health-related quality of life and pelvic pain. The study is a proof-of-concept single-arm pilot, focusing on improving adherence to vaginal dilator therapy, which is crucial for preventing vaginal stenosis post-radiation. Participants will be monitored for 12 weeks during the intervention period.
Who should consider this trial
Good fit: Ideal candidates are post-menopausal women or surgically sterile individuals who have completed radiation therapy for specific pelvic cancers and are generally in good health.
Not a fit: Patients currently undergoing chemotherapy or those with severe health issues unrelated to cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve adherence to vaginal dilator therapy, enhancing quality of life for patients recovering from pelvic radiation therapy.
How similar studies have performed: While traditional vaginal dilator therapy has been used, the novel approach of the Hyivy device represents a new and untested method in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kitchener, Ontario
- Grand River Regional Cancer Centre, Waterloo Regional Health Network @ Midtown — Kitchener, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Daniel Glick, MD — Grand River Hospital
- Study coordinator: Daniel Glick, MD
- Email: Daniel.Glick@grhosp.on.ca
- Phone: (519) 749-4370
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.