Feasibility of Hyivy Device Post-Radiation for Pelvic Malignancies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHyivy Health Inc
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 also evaluating changes in health-related quality of life and pelvic pain.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Hyivy Intravaginal Device
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Hyivy Health Inc
Lead sponsor
Grand River Hospital
Collaborator
Source ClinicalTrials.gov