New device aims to prevent vaginal scarring after cancer radiation
NCT ID NCT07473271
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special device that combines a vaginal dilator with a drug delivery tube to help prevent vaginal narrowing and scarring after pelvic radiation therapy. About 76 women aged 18-70 who have completed radiation for pelvic tumors will use the device regularly. The goal is to see if it reduces vaginal side effects and improves quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 76 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. women aged 18 to 70 years. 2. After radiotherapy for pelvic tumors, the tumor is well controlled (no macroscopically visible tumor). At least 1 week after radiotherapy, regular vaginal dilation and irrigation are expected to be performed subsequently. 3. ECOG 0-2. 4. prospected survival greater than 6 months. 5. Good communication skills, no history of mental illness. 6. Consent to participate in this trial and voluntarily sign the informed consent form. Exclusion Criteria: 1. Malignant tumors in other parts of the body. 2. congenital vaginal stenosis or pre-enrollment confirmed vaginal stenosis. 3. Allergic to silica gel and polyvinyl chloride materials. 4. active vaginal bleeding. 5. It is anticipated that cooperation with the treatment will not be possible. 6. The disease may cause difficulties in treatment and evaluation (e.g., sepsis, inability of the patient to tolerate treatment, etc.). 7. pregnant and lactating women. 8. Participated in other clinical trials involving drugs or medical devices within the past 3 months. 9. The investigators consider other conditions unsuitable for participation in this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730, China
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Other studies related to the condition(s) this trial covers.
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