Feasibility of Hyivy Device Post-Radiation for Pelvic Malignancies

Recruiting N/A Interventional Study
Vaginal Stenosis Radiation Therapy Cancer Pelvic Pain Pelvic Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
12 (estimated)
Sponsor
Hyivy Health Inc · Industry
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About This Trial
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 al…
Trial Locations
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Eligibility 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 ch…
Contacts

Daniel Glick, MD

(519) 749-4370

Daniel.Glick@grhosp.on.ca

CONTACT