Hyivy Device in Post-radiation Patients

Sponsor

Hyivy Health Inc (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05648253

Collaborator

Grand River Hospital (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Vaginal Stenosis Radiation Therapy Cancer	Device: Vingal Dilator Therapy by Hyivy device	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

A prospective single-arm pre/post repeated-measures pilot intervention studyA prospective single-arm pre/post repeated-measures pilot intervention study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 31, 2023

Anticipated Primary Completion Date :

Aug 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hyivy Device 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: Vingal Dilator Therapy by Hyivy device 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

Arm

Intervention/Treatment

Experimental: Hyivy Device

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: Vingal Dilator Therapy by Hyivy device

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

Outcome Measures

Primary Outcome Measures

The usability and satisfaction of the Hyivy device by study-specific questionnaire [12 weeks]
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)

Secondary Outcome Measures

Changes in quality of life [12 weeks]
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.
Changes in sexual function as assessed by the EORTC-SHQ-22 [12 weeks]
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.
Changes in pelvic pain as assessed by visual analog scale (VAS). [12 weeks]
Changes in pelvic pain as assessed by visual analog scale (VAS) ranging from 0 (no discomfort) to 10 (severe discomfort)
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). [12 weeks]
Safety of the Hyivy device assessed by the Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)
The adherence of the Hyivy device assessed by participants' compliance [12 weeks]
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%)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hyivy Health Inc
Grand River Hospital

Investigators

Principal Investigator: Daniel Glick, MD, Grand River Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Hyivy Health Inc

ClinicalTrials.gov Identifier:

NCT05648253

Other Study ID Numbers:

Hyivy Health Inc-11 Nov 2022

First Posted:

Dec 13, 2022

Last Update Posted:

Jan 6, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hyivy Health Inc

Dilator

Post Radiation therapy

Study Results

No Results Posted as of Jan 6, 2023