Hyivy Device as Non-hormonal Therapy in Endometriosis

Launched by HYIVY HEALTH INC · Dec 1, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new device called the Hyivy, which is designed to help manage chronic pelvic pain related to endometriosis without using hormones. The goal is to see if using this device at home can reduce the pain that many women experience due to this condition. The study will involve women aged 18 and older who have been diagnosed with endometriosis and are currently experiencing persistent pelvic pain. To qualify, participants must have been using certain hormonal treatments for at least three months and agree not to start any new treatments during the 12-week study period.

Participants in this trial will use the Hyivy device and report on their pain levels over time. They will need to attend a few scheduled visits to discuss their experiences and complete some assessments. It's important for potential participants to know that they must be in generally good health aside from their endometriosis and must not have any conditions or infections that could complicate the study. If you or someone you know is interested in learning more about this trial, please keep in mind that it is not yet recruiting participants.

Gender

FEMALE

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, including hormonal therapies for any medical condition, and complimentary and/or alternative management of surgery for endometriosis and associated chronic pain
• • 8.Agrees not to undergo pelvic physiotherapy with a trained professional during the study
• • 9.Agrees to avoid taking non-steroidal anti-inflammatory drugs (e.g., ibuprofen) for 72 hours before Visits 1, 2, and 3
• • 10.Must have the ability to charge the investigational device
• • 11.Must be willing and able to insert intravaginal device
• • 12.Able to understand, comply and consent to protocol requirements and instructions
• • 13.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.Any other medical condition or clinical finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational product or that may affect the interpretation of the results or leave the patient at high risk from treatment complications, at the discretion of the investigator(s)
• • 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) or infection in the pelvic area
• • 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
• • 10.Have open wounds, cuts, or open sores present in vaginal or pelvic area
• • 11.Severe atrophic vaginitis or very dry, itchy, or sore vagina/vaginal area, at the discretion of the primary investigator(s)
• • 12.Hypoesthesia or loss in sensation of the pelvic floor
• • 13.Total and/or partial prolapse of the uterus and/or vagina
• • 14.Symptoms of severe urinary retention, severe extra-urethral incontinence or overflow incontinence
• • 15.Unable to position the device according to directions for use
• • 16.Use of any medical devices that may interfere with the investigational device's function, such as pacemakers, ventilators, and ear implants