Hyivy Device for Pelvic Cancer

Overseen By Daniel Glick, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Hyivy Health Inc

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Major surgery, Infections, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Hyivy Device, designed to assist individuals who have undergone radiation therapy for pelvic cancer. Used at home, the device aids in vaginal dilation, potentially improving pelvic pain and quality of life. Participants must have completed radiation therapy for specific cancers, such as endometrial or cervical cancer, and must refrain from using other dilators during the trial. The study aims to determine if the device is safe and comfortable to use.

As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance post-radiation therapy care.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot use other vaginal dilators during the 12-week intervention period.

What prior data suggests that the Hyivy device is safe for use in pelvic cancer patients?

Research is testing the Hyivy Device to evaluate its safety and comfort for patients. This innovative device, used inside the vagina, allows users to adjust its size, unlike the fixed-size dilators typically used after radiation therapy for pelvic or vaginal cancer.

Detailed information about its safety in humans is limited because the study is in an early stage, so data on side effects may be sparse. However, these early studies are crucial to determine if the device is generally safe for use.

If the device shows manageable side effects, it could become a promising option for those recovering from pelvic cancer treatments. Watch for more results as the study progresses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Hyivy Device is unique because it offers a new at-home treatment option for pelvic cancer survivors using a combination of heat therapy and dilation. Unlike standard treatments that often involve medication or surgery, this device provides a non-invasive approach that can be used comfortably in the privacy of one's home. Researchers are excited because this method could improve pelvic health by enhancing blood flow and flexibility, potentially reducing symptoms like pain and discomfort more conveniently than traditional therapies.

What evidence suggests that the Hyivy device is effective for pelvic cancer?

Research has shown that traditional vaginal dilator therapy after pelvic radiation can be uncomfortable and difficult to continue. In this trial, participants will use the Hyivy device, designed to ease this process by allowing patients to control the dilation themselves. Early findings suggest that adding heat and enabling user control might enhance comfort and effectiveness. Although large-scale data is not yet available, the device aims to improve quality of life and reduce pelvic pain. Early users found it safe and tolerable. This new method aims to provide better results for those recovering from pelvic cancer treatment. ^{1 3 4 6 7}

Who Is on the Research Team?

Daniel Glick, MD

Principal Investigator

Grand River Hospital

Are You a Good Fit for This Trial?

This trial is for individuals aged 18 or older who have completed radiation therapy for certain pelvic cancers (endometrial, cervical, anal, rectal) without concurrent chemotherapy. Participants must not be of child-bearing potential or agree to use birth control and cannot start new treatments during the study. They should be able to follow instructions, attend visits, charge and insert the device themselves.

Inclusion Criteria

Generally in good health (other than due to cancer), at the discretion of the investigator(s)

Agree not to use other dilators for the 12-week intervention period

Able to attend scheduled study visits and complete required investigations

Exclusion Criteria

Participants who are pregnant or planning to become pregnant during the trial

Allergy to Hyivy device's materials

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)

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, with each session consisting of 10 minutes of heat and 10 minutes of dilation.

12 weeks

At-home use

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life and pelvic pain.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyivy Device

Trial Overview The trial is testing a novel intravaginal device called Hyivy that allows patient-controlled dilation after pelvic radiation therapy. It's a single-arm pilot study focusing on safety and tolerability while also observing any changes in quality of life and pelvic pain levels.

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+

Grand River Hospital

Collaborator

Trials

7

Recruited

1,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05648253

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 is designed as a ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/record/NCT05648253?recrs=ab

Feasibility of Hyivy Device Post-Radiation for Pelvic ... Vaginal dilator therapy (VDT) with static dilators is often prescribed to patients following vaginal or pelvic radiation therapy. This study seeks to evaluate ...

3. trialx.com trialx.com/clinical-trials/listings/297092/feasibility-of-hyivy-device-post-radiation-for-pelvic-malignancies/

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 ...

4. 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 ...

5. syscreations.ca syscreations.ca/blog/hyivy-health/

Hyivy Health: Women's Health Startup That Aims to Improve ... With the app, patients will be able to access their pelvic health data collected from the device, track their progress, and have on-demand virtual sessions with ...

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. oicr.on.ca oicr.on.ca/new-tech-could-modernize-recovery-from-gynecological-cancers/

New tech could modernize recovery from gynecological ... A new patient-centred technology to help women recover from pelvic health problems caused by cancer and other gynecological conditions.