Evaluating a new device for vaginal dilation after pelvic radiation therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Grand River Regional Cancer Centre, Waterloo Regional Health Network @ Midtown
  Kitchener, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Daniel Glick, MD — Waterloo Regional Health Network
• Study coordinator: Daniel Glick, MD
• Email: Daniel.Glick@grhosp.on.ca
• Phone: (519) 749-4370

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.