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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Hyivy Intravaginal Device
DeviceIntravaginal use of Hyivy device three times per week for 12 weeks, with each session consisting of 10 minutes of heat (37-39ºC) and 10 minutes of dilation.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Hyivy Intravaginal DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability of the Hyivy device
Occurrence of adverse events (AE) and serious adverse events (SAE).
Time frame
Up to 12-weeksSecondary outcomes
1
Quality of Life (FACT-G)
Changes in health-related quality of life (HRQoL) as assessed by the Functional Assessment of Cancer Therapy - General (FACT-G).
Time frame
Baseline, 6-weeks, 12-weeks2
Pelvic pain (VAS)
Changes in pelvic pain as assessed by a visual analog scale (VAS).
Time frame
Baseline, 6-weeks, 12-weeks3
Adherence to study protocol
Usage data collected by the Hyivy device will be used to assess participant adherence to the study regimen of 3 times/week device use.
Time frame
6-weeks, 12-weeksOther outcomes
1
Device usability and patient satisfaction
Study-specific questionnaire to gather patient feedback
Time frame
12-weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hyivy Health Inc
Lead sponsor
Grand River Hospital
Collaborator
Source ClinicalTrials.gov