Feasibility of Hyivy Device Post-Radiation for Pelvic Malignancies

Launched by HYIVY HEALTH INC · Dec 5, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new device called the Hyivy device, which is designed to help women who have experienced vaginal changes after receiving radiation therapy for pelvic cancers like endometrial, cervical, anal, or rectal cancer. The goal is to see if this device can safely and effectively help women manage vaginal narrowing (known as vaginal stenosis) and improve their quality of life and pelvic pain. The trial is currently looking for female participants aged 18 and older who have completed radiation therapy and are generally in good health, with a few specific criteria to ensure safety during the study.

Participants in this trial will use the Hyivy device, which allows them to control how much it expands, making it easier and potentially more comfortable to use compared to traditional dilators. They will not be allowed to use any other dilators during the 12-week study period. Throughout the trial, participants can expect regular check-ins to monitor their health and how well they are adapting to the device. If you're interested in participating, it's important to know that this study excludes individuals with certain medical conditions or those who are pregnant, as well as those who have had major surgeries recently.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1.Age ≥ 18 at the time of enrollment
• • 2.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
• • 3.Generally in good health (other than due to cancer), at the discretion of the investigator(s)
• • 4.Eastern Cooperative Oncology Group (ECOG) score or 0 to 2
• • 5.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.
• • 6.Agree not to use other dilators for the 12-week intervention period
• • 7.Must have the ability to charge the investigational device
• • 8.Must be willing and able to insert intravaginal device
• • 9.Able to understand, comply and consent to protocol requirements and instructions
• • 10.Able to attend scheduled study visits and complete required investigations
• • 11.Ability to understand and willingness to sign written informed consent
• Exclusion Criteria:
• • 1.Participants who are pregnant or planning to become pregnant during the trial
• • 2.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
• • 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.Allergy to Hyivy device's materials
• • 5.Active pelvic or gynaecological infection
• • 6.Current use of antibiotics for any infection
• • 7.Have open wounds, cuts, or open sores present in the vaginal or pelvic area
• • 8.Severe atrophic vaginitis or very dry, itchy, or sore vagina/vaginal area, at the discretion of the investigator(s)
• • 9.Hypoesthesia or loss in sensation of the pelvic floor
• • 10.Total and/or partial prolapse of the uterus and/or vagina
• • 11.Symptoms of severe urinary retention, severe extra-urethral incontinence, or overflow incontinence
• • 12.Unable to position the device according to directions for use
• • 13.Use of any medical devices that may interfere with the investigational device's function, such as pacemakers, ventilators, and ear implants