Pilot Study to Assess the Feasibility of Use of a Novel Vaginal Dilator Device Post-radiation for Patients With Pelvic Malignancies
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.
• 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