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Hyivy Device for Endometriosis (endometriosis Trial)
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Waitlist Available
Research Sponsored by Hyivy Health Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
4.Diagnosed with chronic pelvic pain (self-reported pain in pelvic area lasting >3 months)
VAS for overall pelvic pain ≥ 4 at screening and baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
endometriosis Trial Summary
This trial tests if a device called Hyivy can reduce pelvic pain in people with endometriosis.
Who is the study for?
This trial is for adults over 18 with endometriosis and chronic pelvic pain lasting more than 3 months. Participants must be in good health otherwise, have been managing endometriosis with hormones for at least 3 months, and be willing to use an intravaginal device. They can't start new treatments or physiotherapy during the study, nor have conditions like active infections or recent surgeries that could interfere.Check my eligibility
What is being tested?
The Hyivy device is being tested to see if it reduces self-reported pelvic pain in individuals with endometriosis. The study involves participants using this intravaginal device regularly and monitoring their pain levels without starting any other new treatments.See study design
What are the potential side effects?
Potential side effects are not specified but may include discomfort or reactions related to inserting the intravaginal device, based on individual sensitivities to the material of the Hyivy device.
endometriosis Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had pelvic pain for more than 3 months.
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My pelvic pain level is 4 or higher.
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I can charge the device needed for the trial.
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I am willing and able to use an intravaginal device.
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I am 18 years old or older.
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I am 18 years old or older.
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I have been diagnosed with endometriosis.
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I agree not to start any new treatments for 12 weeks.
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I have had pelvic pain for more than 3 months.
endometriosis Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
overall self-reported pelvic pain
Secondary outcome measures
The adherence of the Hyivy device assessed by participants' compliance
The usability and satisfaction of the Hyivy device
changes in peripheral inflammation
+6 moreendometriosis Trial Design
1Treatment groups
Experimental Treatment
Group I: Hyivy DeviceExperimental Treatment1 Intervention
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
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Who is running the clinical trial?
Hyivy Health IncLead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
McMaster UniversityOTHER
880 Previous Clinical Trials
2,597,808 Total Patients Enrolled
3 Trials studying Endometriosis
74 Patients Enrolled for Endometriosis
Lois Lin, Dr.Study DirectorHyivy Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to the materials used in the Hyivy device.I do not have an active vaginal infection.I have been treating my endometriosis with hormones non-stop for 3 months.I am currently taking antibiotics and have had yeast infections before.I have had pelvic pain for more than 3 months.My pelvic pain level is 4 or higher.You are in good health overall, except for endometriosis, according to your doctor's assessment.I agree not to have pelvic physiotherapy with a professional during the study.I can charge the device needed for the trial.I have had surgery in the last 3 months or expect to have surgery during the study.I agree not to have pelvic physiotherapy with a professional during the study.I am willing and able to use an intravaginal device.I am 18 years old or older.I am 18 years old or older.I have chronic pelvic pain not caused by endometriosis.I understand and am willing to participate in the study.I have been diagnosed with early menopause.You are in good health, except for endometriosis, as determined by your doctor.I have been diagnosed with endometriosis.I agree not to start any new treatments for 12 weeks.I am currently seeing a pelvic floor physiotherapist.I have had pelvic pain for more than 3 months.I understand and can follow the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Hyivy Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled vacancies in this study that participants could apply for?
"The information hosted on clinicaltrials.gov suggests that this medical trial is not currently in a position to recruit participants. It was initially posted January 1st 2023 and the most recent update happened December 1st 2022. However, there are presently 118 other trials seeking out individuals for their research efforts."
Answered by AI
Who else is applying?
What state do they live in?
Ontario
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Recent research and studies
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