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New treatment option for Vaginal Stenosis
Official title Feasibility of Hyivy Device Post-Radiation for Pelvic Malignancies
ClinicalTrials.gov ID: NCT05648253
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 3.Any other medical condition or clinical finding giving reasonable suspicion of a disease or condition that contraindicates the use of the...
- 4.Allergy to Hyivy device's materials
- 5.Active pelvic or gynaecological infection
- 6.Current use of antibiotics for any infection
See the full eligibility 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...
- 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Kitchener, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kitchener, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.