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.
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…
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