Hyivy Device for Endometriosis

(endometriosis Trial)

Overseen By Mathew Leonardi, M.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Hyivy Health Inc

Must be taking: Hormonal medications

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Vaginal infections, Surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new device, the Hyivy device, to help manage chronic pelvic pain in people with endometriosis. The device, used at home, combines heat and dilation to reduce pain. Participants will use it three times a week for 12 weeks. Individuals who have experienced endometriosis-related pelvic pain for more than three months and currently manage their condition with hormonal medication might be a good fit. As an unphased trial, this study offers a unique opportunity to explore innovative pain management solutions in a real-world setting.

Do I need to stop my current medications for the trial?

You do not need to stop your current hormonal medications for endometriosis, but you must not start any new treatments during the 12-week study. You should also avoid taking non-steroidal anti-inflammatory drugs (like ibuprofen) for 72 hours before certain study visits.

What prior data suggests that the Hyivy device is safe for managing endometriosis-associated chronic pelvic pain?

Research shows that the Hyivy device offers a non-hormonal option to help manage chronic pelvic pain in endometriosis. Earlier studies found that patients could easily use it at home. These studies primarily assessed the device's practicality and the level of control patients have over their treatment, which includes gentle heat and stretching.

Another study examined the Hyivy device's use in patients with pelvic cancer. It found that most people used it without major issues, and any side effects were manageable. This suggests potential safety for those with endometriosis, although specific information on side effects for endometriosis patients is not yet available.

The trial is in an early "proof-of-concept" stage, meaning the device is still being tested for effectiveness and safety. However, its use in other conditions suggests potential safety. Always consult a healthcare provider for personal advice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for endometriosis, which often include hormonal therapies and surgical interventions, the Hyivy device offers a non-invasive approach with its unique intravaginal application. This device combines gentle heat therapy (37-39ºC) with dilation, aiming to alleviate symptoms by relaxing pelvic muscles and improving blood flow. Researchers are excited about this treatment because it allows for at-home use, offering a convenient, potentially less intrusive option that could enhance the quality of life for individuals with endometriosis.

What evidence suggests that the Hyivy device is effective for managing endometriosis-associated chronic pelvic pain?

Research has shown that the Hyivy device, used by participants in this trial, might help reduce pelvic pain for people with endometriosis. This device is easy to use at home, offering a convenient option for managing ongoing pain. Early results suggest that heat and gentle stretching can relieve pain. Although the device is new, initial signs indicate its potential to ease pain related to endometriosis. ^{1 3 4 6 7}

Who Is on the Research Team?

Mathew Leonardi, M.D.

Principal Investigator

McMaster University Medical Centre

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Must be willing and able to insert intravaginal device

I have been treating my endometriosis with hormones non-stop for 3 months.

Agrees not to commence any new treatments for the 12-week intervention period

Exclusion Criteria

You are allergic to the materials used in the Hyivy device.

I do not have an active vaginal infection.

Pregnant or lactating

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Hyivy intravaginal device at home, three times per week for 12 weeks

12 weeks

Baseline, 6-week, and 12-week assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyivy device

Trial Overview 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.

How Is the Trial Designed?

Group I: Hyivy Intravaginal Device Experimental Treatment 1 Intervention

Participants will receive a Hyivy intravaginal device for at-home use. Recommended use is three times per week for 12 weeks and consists of 10 minutes of heat (37-39ºC) and 10 minutes of dilation per session.

Who Is Running the Clinical Trial?

Hyivy Health Inc

Lead Sponsor

Trials

2

Recruited

30+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Citations

1. trial.medpath.com trial.medpath.com/clinical-trial/2918cd0a5678666a/nct05643131-evaluation-hyivy-device-endometriosis

Hyivy Device as Non-hormonal Therapy in Endometriosis This study seeks to address accessible management of endometriosis-associated chronic pelvic pain by evaluating a novel device used in the home.

2. withpower.com withpower.com/trial/phase-endometriosis-2023-7d526

Hyivy Device for Endometriosis · Info for Participants This trial is testing the Hyivy device, which is designed to help reduce pelvic pain. The study focuses on people with endometriosis, a condition that ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11457249/

Comprehensive endometriosis care: a modern multimodal ... This review provides a nuanced exploration of endometriosis-associated pain management, encompassing medical, surgical, and holistic approaches.

4. futurefemhealth.com futurefemhealth.com/p/hyivy-health-secures-2m-to-improve

Hyivy Health secures $2m to improve pelvic pain treatment ... The data sets from the Hyivy system see promising and exciting results for not just the treatment of pelvic pain, but also potential ...

5. clinconnect.io clinconnect.io/trials/NCT05643131

Hyivy Device as Non-hormonal Therapy in Endometriosis This study seeks to address accessible management of endometriosis-associated chronic pelvic pain by evaluating a novel device used in the home.

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/463995

Feasibility of Hyivy Device Post-Radiation for Pelvic ... This study seeks to evaluate the feasibility of a novel intravaginal device that delivers patient-controlled dilation (Hyivy device). The study ...

7. withpower.com withpower.com/trial/hyivy-device-for-pelvic-cancer-f9f2e

Hyivy Device for Pelvic Cancer This N/A medical study run by Hyivy Health Inc is evaluating whether Hyivy Device will have tolerable side effects & efficacy for patients with Pelvic ...