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

Trial Summary

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.

How does the Hyivy Device treatment for pelvic cancer differ from other treatments?

The Hyivy Device is unique because it is a novel approach specifically designed for pelvic cancer, potentially offering a new method of treatment compared to traditional options like surgery or radiation. While the exact mechanism isn't detailed, its development suggests a focus on innovative technology for targeted therapy. ^{1 2 3 4 5}

What is the purpose of this trial?

Vaginal dilator therapy (VDT) with static dilators is often prescribed to patients following vaginal or pelvic radiation therapy. 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 proof-of-concept single-arm pilot study. The primary objective is to assess safety and tolerability, while also evaluating changes in health-related quality of life and pelvic pain.

Research Team

Daniel Glick, MD

Principal Investigator

Grand River Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[A set of protective technological equipment for intracavitary radiation therapy in oncogynecology]. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Human Papillomavirus Vaccination Prior to Loop Electroexcision Procedure Does Not Prevent Recurrent Cervical High-grade Squamous Intraepithelial Lesions in Women Living With Human Immunodeficiency Virus: A Randomized, Double-blind, Placebo-controlled Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy alone post-hysterectomy for endometrial cancer. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Is surgical plume developing during routine LEEPs contaminated with high-risk HPV? A pilot series of experiments. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Clinical outcomes of vaginectomy and laser ablation for the treatment of post-hysterectomy women with vaginal high-grade squamous intraepithelial lesions: A retrospective study. [2021]