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Hyivy Device in Endometriosis (endometriosis)

Primary Purpose

Endometriosis, Pelvic Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hyivy device
Sponsored by
Hyivy Health Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis, Pelvic Pain, Dilator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 1.Age ≥ 18 at the time of enrollment 2.Generally in good health (other than due to endometriosis), at physician's discretion 3.Diagnosed with endometriosis (clinical, radiologic, or surgical) 4.Diagnosed with chronic pelvic pain (self-reported pain in pelvic area lasting >3 months) 5.VAS for overall pelvic pain ≥ 4 at screening and baseline 6.Medically managing endometriosis using continuous hormonal medications (i.e., oral contraceptive pills, progesterone only pills, Mirena, GnRH agonists/antagonists) for at least 3 months prior to enrollment 7.Agrees not to commence any new treatments (medical or physical therapies) for the 12-week intervention period 8.Agrees not to undergo pelvic physiotherapy with a trained professional during the study 9.Must have the ability to charge the investigational device 10.Must be willing and able to insert intravaginal device 11.Able to understand, comply and consent to protocol requirements and instructions 12.Able to attend scheduled study visits and complete required investigations Exclusion Criteria: 1.Chronic pelvic pain thought to be due to a condition other than endometriosis 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 surgery in the past 3 months or anticipates having surgery during the study 5.Allergy to Hyivy device's materials 6.Active vaginal infection (e.g. vulvovaginal candidiasis, trichomonas vaginitis, bacterial vaginosis, STIs) 7.Current use of antibiotics and a history of vulvovaginal candidiasis 8.Pregnant or lactating 9.Currently under the care of a pelvic floor physiotherapist Pre-study washout: If potential study participants are pregnant, lactating, or initiating hormonal contraceptives, their eligibility to participate in the study can be re-evaluated after 3 months of hormonal contraceptive use prior to enrollment. If potential study participants have an active vaginal infection or are currently using antibiotics with a history of vulvovaginal candidiasis, their eligibility to participate in the study can be re-evaluated after treatment, and resolution of the infection.

Sites / Locations

  • McMaster University Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyivy Device

Arm Description

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

Outcomes

Primary Outcome Measures

overall self-reported pelvic pain
Change in overall pelvic pain will be evaluated using a digital visual analog scale (VAS) ranging from 0 (no discomfort) to 10 (severe discomfort)

Secondary Outcome Measures

site-specific tenderness and pelvic floor muscle pain
site-specific tenderness and pelvic floor muscle pain will be measured by Biberoglu and Behrman scale (B&B) ranging from 0 (none) to 15 (severe)
changes in quality of life
changes in quality of life as assessed by the Endometriosis Health Profile-30 (EHP-30) ranging from 0 (best possible health status) to 100 (worst possible health status)
sexual function
changes in sexual function as assessed by the Female Sexual Function Index (FSFI). The female sexual function index (FSFI) is a measure of sexual functioning in women. Scores range from 2 to 36 with higher scores indicating greater functioning.
changes in the use of rescue medications and Emergency rooms visits
changes in the use of rescue medications and Emergency rooms visits as assessed by a study-specific questionnaire
changes in peripheral inflammation
changes in Peripheral Inflammatory Protein Expression as assessed by an inflammatory multiplexed protein biomarker assay(a protein biomarker panel) from blood draw
feasibility of the Hyivy device
feasibility of the Hyivy device as a non-hormonal therapy in people with endometriosis as evaluated by review of participant subjective questionnaires(such as device size, easy to insert, hold and remove).
safety and tolerability of the Hyivy device assessed by the Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)
safety and tolerability of the Hyivy device as a non-hormonal therapy in people with endometriosis as assessed by review of adverse events (AE) and serious adverse events (SAE).
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%)
The usability and satisfaction of the Hyivy device
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)

Full Information

First Posted
August 18, 2022
Last Updated
September 26, 2023
Sponsor
Hyivy Health Inc
Collaborators
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT05643131
Brief Title
Hyivy Device in Endometriosis
Acronym
endometriosis
Official Title
Evaluation of the Hyivy Device as a Non-hormonal Therapy in People With Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 30, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hyivy Health Inc
Collaborators
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to evaluate the effect of using the Hyivy device on overall self-reported pelvic pain in people with endometriosis
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Pelvic Pain
Keywords
Endometriosis, Pelvic Pain, Dilator

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective observational single-arm pre/post repeated-measures pilot intervention study
Masking
None (Open Label)
Masking Description
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyivy Device
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Hyivy device
Intervention Description
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
Primary Outcome Measure Information:
Title
overall self-reported pelvic pain
Description
Change in overall pelvic pain will be evaluated using a digital visual analog scale (VAS) ranging from 0 (no discomfort) to 10 (severe discomfort)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
site-specific tenderness and pelvic floor muscle pain
Description
site-specific tenderness and pelvic floor muscle pain will be measured by Biberoglu and Behrman scale (B&B) ranging from 0 (none) to 15 (severe)
Time Frame
12 weeks
Title
changes in quality of life
Description
changes in quality of life as assessed by the Endometriosis Health Profile-30 (EHP-30) ranging from 0 (best possible health status) to 100 (worst possible health status)
Time Frame
12 weeks
Title
sexual function
Description
changes in sexual function as assessed by the Female Sexual Function Index (FSFI). The female sexual function index (FSFI) is a measure of sexual functioning in women. Scores range from 2 to 36 with higher scores indicating greater functioning.
Time Frame
12 weeks
Title
changes in the use of rescue medications and Emergency rooms visits
Description
changes in the use of rescue medications and Emergency rooms visits as assessed by a study-specific questionnaire
Time Frame
12 weeks
Title
changes in peripheral inflammation
Description
changes in Peripheral Inflammatory Protein Expression as assessed by an inflammatory multiplexed protein biomarker assay(a protein biomarker panel) from blood draw
Time Frame
12 weeks
Title
feasibility of the Hyivy device
Description
feasibility of the Hyivy device as a non-hormonal therapy in people with endometriosis as evaluated by review of participant subjective questionnaires(such as device size, easy to insert, hold and remove).
Time Frame
12 weeks
Title
safety and tolerability of the Hyivy device assessed by the Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)
Description
safety and tolerability of the Hyivy device as a non-hormonal therapy in people with endometriosis as assessed by review of adverse events (AE) and serious adverse events (SAE).
Time Frame
12 weeks
Title
The adherence of the Hyivy device assessed by participants' compliance
Description
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%)
Time Frame
12 weeks
Title
The usability and satisfaction of the Hyivy device
Description
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)
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.Age ≥ 18 at the time of enrollment 2.Generally in good health (other than due to endometriosis), at physician's discretion 3.Diagnosed with endometriosis (clinical, radiologic, or surgical) 4.Diagnosed with chronic pelvic pain (self-reported pain in pelvic area lasting >3 months) 5.VAS for overall pelvic pain ≥ 4 at screening and baseline 6.Medically managing endometriosis using continuous hormonal medications (i.e., oral contraceptive pills, progesterone only pills, Mirena, GnRH agonists/antagonists) for at least 3 months prior to enrollment 7.Agrees not to commence any new treatments (medical or physical therapies) for the 12-week intervention period 8.Agrees not to undergo pelvic physiotherapy with a trained professional during the study 9.Must have the ability to charge the investigational device 10.Must be willing and able to insert intravaginal device 11.Able to understand, comply and consent to protocol requirements and instructions 12.Able to attend scheduled study visits and complete required investigations Exclusion Criteria: 1.Chronic pelvic pain thought to be due to a condition other than endometriosis 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 surgery in the past 3 months or anticipates having surgery during the study 5.Allergy to Hyivy device's materials 6.Active vaginal infection (e.g. vulvovaginal candidiasis, trichomonas vaginitis, bacterial vaginosis, STIs) 7.Current use of antibiotics and a history of vulvovaginal candidiasis 8.Pregnant or lactating 9.Currently under the care of a pelvic floor physiotherapist Pre-study washout: If potential study participants are pregnant, lactating, or initiating hormonal contraceptives, their eligibility to participate in the study can be re-evaluated after 3 months of hormonal contraceptive use prior to enrollment. If potential study participants have an active vaginal infection or are currently using antibiotics with a history of vulvovaginal candidiasis, their eligibility to participate in the study can be re-evaluated after treatment, and resolution of the infection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyle McGowan, H.B.Sc
Phone
905-521-2100
Ext
21334
Email
mcgowank@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mathew Leonardi, Dr.
Phone
905-521-2100
Ext
76252
Email
leonam@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardi Leonardi, Dr.
Organizational Affiliation
McMaster University Medical Centre
Official's Role
Study Director
Facility Information:
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers
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