Feasibility of Hyivy Device Post-Radiation for Pelvic Malignancies

NCT05648253 | Recruiting

• 1 other identifier: HYV-002-C23
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaginal Stenosis; Radiation Therapy; Cancer; Pelvic Pain; Pelvic Cancer

Keywords

Dilator; Post radiation therapy

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of the Hyivy device

  Occurrence of adverse events (AE) and serious adverse events (SAE).

  Up to 12-weeks

Secondary Outcomes (3)

• Quality of Life (FACT-G)

  Baseline, 6-weeks, 12-weeks

• Pelvic pain (VAS)

  Baseline, 6-weeks, 12-weeks

• Adherence to study protocol

  6-weeks, 12-weeks

Other Outcomes (1)

• Device usability and patient satisfaction

  12-weeks

Study Arms (1)

Hyivy Intravaginal Device

EXPERIMENTAL

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.

Device: Hyivy Intravaginal Device

Interventions

Hyivy Intravaginal Device DEVICE

Intravaginal use of Hyivy device three times per week for 12 weeks, with each session consisting of 10 minutes of heat (37-39ºC) and 10 minutes of dilation.

Hyivy Intravaginal Device

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 at the time of enrollment
• Patient with a vagina or vaginal canal who have completed radiation therapy (either external beam or brachytherapy, or a combination of both) for endometrial cancer, cervical cancer, anal cancer, or rectal cancer, without concomitant chemotherapy
• Generally in good health (other than due to cancer), at the discretion of the investigator(s)
• Eastern Cooperative Oncology Group (ECOG) score or 0 to 2
• Participants must be post-menopausal (natural or surgically) for at least 1 year prior to screening or be surgically sterile (absence of ovaries and/or uterus); or, a participant of child-bearing potential must agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months.
• Agree not to use other dilators for the 12-week intervention period
• Must have the ability to charge the investigational device
• Must be willing and able to insert intravaginal device
• Able to understand, comply and consent to protocol requirements and instructions
• Able to attend scheduled study visits and complete required investigations
• Ability to understand and willingness to sign written informed consent

You may not qualify if:

• Participants who are pregnant or planning to become pregnant during the trial
• Any major surgery in the past 3 months unless post-surgery dilator use is recommended by a physician, or anticipates having a major surgery during the study
• 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)
• Allergy to Hyivy device's materials
• Active pelvic or gynaecological infection
• Current use of antibiotics for any infection
• Have open wounds, cuts, or open sores present in the vaginal or pelvic area
• Severe atrophic vaginitis or very dry, itchy, or sore vagina/vaginal area, at the discretion of the investigator(s)
• Hypoesthesia or loss in sensation of the pelvic floor
• Total and/or partial prolapse of the uterus and/or vagina
• Symptoms of severe urinary retention, severe extra-urethral incontinence, or overflow incontinence
• Unable to position the device according to directions for use
• Use of any medical devices that may interfere with the investigational device's function, such as pacemakers, ventilators, and ear implants

Sponsors & Collaborators

• Hyivy Health Inc: lead
• Grand River Hospital: collaborator

Study Sites (1)

Grand River Regional Cancer Centre, Waterloo Regional Health Network @ Midtown

Kitchener, Ontario, N2G 1G3, Canada

RECRUITING

Related Publications (5)

• Damast S, Jeffery DD, Son CH, Hasan Y, Carter J, Lindau ST, Jhingran A. Literature Review of Vaginal Stenosis and Dilator Use in Radiation Oncology. Pract Radiat Oncol. 2019 Nov;9(6):479-491. doi: 10.1016/j.prro.2019.07.001. Epub 2019 Jul 11.

  PMID: 31302301 BACKGROUND

• International Clinical Guideline Group. International Guidelines on Vaginal Dilation after Pelvic Radiotherapy.; 2012. https://owenmumford.com/us/wp-content/uploads/sites/3/2014/11/Dilator-Best-Practice-Guidelines.pdf.

  BACKGROUND

• Law E, Kelvin JF, Thom B, Riedel E, Tom A, Carter J, Alektiar KM, Goodman KA. Prospective study of vaginal dilator use adherence and efficacy following radiotherapy. Radiother Oncol. 2015 Jul;116(1):149-55. doi: 10.1016/j.radonc.2015.06.018. Epub 2015 Jul 8.

  PMID: 26164775 BACKGROUND

• Bakker RM, Vermeer WM, Creutzberg CL, Mens JW, Nout RA, Ter Kuile MM. Qualitative accounts of patients' determinants of vaginal dilator use after pelvic radiotherapy. J Sex Med. 2015 Mar;12(3):764-73. doi: 10.1111/jsm.12776. Epub 2014 Nov 25.

  PMID: 25424559 BACKGROUND

• Araya-Castro P, Sacomori C, Diaz-Guerrero P, Gayan P, Roman D, Sperandio FF. Vaginal Dilator and Pelvic Floor Exercises for Vaginal Stenosis, Sexual Health and Quality of Life among Cervical Cancer Patients Treated with Radiation: Clinical Report. J Sex Marital Ther. 2020;46(6):513-527. doi: 10.1080/0092623X.2020.1760981. Epub 2020 May 2.

  PMID: 32364016 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Pelvic Pain; Pelvic Neoplasms

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site

Study Officials

• Daniel Glick, MD

  Grand River Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Glick, MD

CONTACT

(519) 749-4370; Daniel.Glick@grhosp.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective single-arm pre/post repeated-measures pilot study

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: April 11, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)