Hyivy Device in Post-radiation Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the feasibility of using the Hyivy device as a non-hormonal therapy in post-radiation patients with pelvic malignancies

Detailed Description
-----------------
Prior to study enrollment, all prospective participants will have the ability to contact the study team to learn more about the study and be provided with the relevant study-specific information. After being informed about the study and potential risks, all participants giving written informed consent will be assessed for their eligibility for the study, and enrolled participants will undergo a maximum 30-day screening period. On Day 0, eligible participants will start a 12-week use of Hyivy device with one visit on Week 6-7 and another on Week 12. After completing the 12-week intervention period, a virtual follow-up will be conducted on Week 16.

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

Conditions
-----------------
Cancer, Vaginal Stenosis, Radiation Therapy

Intervention / Treatment
-----------------
* Device: Vaginal Dilator Therapy by Hyivy device


Participation Criteria
=================
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 at least 2 weeks prior to starting the intervention, without concomitant chemotherapy 3.The participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening. Or, a participant of child-bearing potential must have a negative baseline urine pregnancy test and 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 4.Agrees not to commence any new treatments (medical or physical therapies) for the 12-week intervention period 5.Must have the ability to charge the investigational device 6.Must be willing and able to insert intravaginal device 7.Able to understand, comply and consent to protocol requirements and instructions 8.Able to attend scheduled study visits and complete required investigations 9.Eastern Cooperative Oncology Group (ECOG) of 0 to 2 10.Ability to understand and willingness to sign written informed consent 11.Healthy as determined by laboratory results, medical history, and physical exam as assessed by qualified investigator Exclusion Criteria: 1.Participants who are pregnant or planning to become pregnant during the trial 2.Diagnosis of premature ovarian insufficiency 3.Has a condition rendering them unable to understand the nature, scope and possible consequences of the study, or evidence of an uncooperative attitude 4.Any major surgery in the past 3 months or anticipates having a major surgery during the study 5.Allergy to Hyivy device's materials (silicone, plastic, and/or metals) 6.Active vaginal infection (e.g., vulvovaginal candidiasis, trichomonas vaginitis, bacterial vaginosis, sexual transmitted infections) Current use of antibiotics and a history of vulvovaginal candidiasis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective single-arm pre/post repeated-measures pilot intervention study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyivy Device<br>Participants will receive a Hyivy device with both verbal and written instructions. Recommended use is three times per week for 12 weeks and consists of: 10 minutes of heat (37-42ºC) per session and 10 minutes of dilation per session | Device: Vaginal Dilator Therapy by Hyivy device<br>* Intravaginal use of Hyivy device three times per week for 12 weeks, with each use session consisting of: 10 minutes of heat (37-42ºC) and 10 minutes of dilation therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The usability and satisfaction of the Hyivy device by study-specific questionnaire | The usability and satisfaction of the Hyivy device for Hyivy's product development as assessed by study-specific questionnaires ranging from 11 (worst usability and satisfaction) to 55 (best usability and satisfaction) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in quality of life | Changes in quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status indicate a better state of the patient, while higher scores on the symptom and single-item scales indicate a worse state of the patient. | 12 weeks | 
| Changes in sexual function as assessed by the EORTC-SHQ-22 | Changes in sexual function as assessed by the EORTC-SHQ-22. The EORTC-SHQ-22 score range is from 0 to 100; a higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms. | 12 weeks | 
| Changes in pelvic pain as assessed by visual analog scale (VAS). | Changes in pelvic pain as assessed by visual analog scale (VAS) ranging from 0 (no discomfort) to 10 (severe discomfort) | 12 weeks | 
| Safety and tolerability of the Hyivy device as a non-hormonal therapy in post- radiation patients with pelvic malignancies as assessed by review of adverse events (AE) and serious adverse events (SAE). | Safety of the Hyivy device assessed by the Number of participants with treatment-related adverse events as assessed by CTCAE v4.0) | 12 weeks | 
| The adherence of the Hyivy device assessed by participants' compliance | Adherence to the study regimen as assessed by comparing usage data collected by the Hyivy device to the recommended intervention regimen(adherence rate = # of times of patients did dilation therapy/# of times of patients should do dilation therapy *100%) | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dilator, Post Radiation therapy