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NCT05224869 · ClinicalTrials.gov registry record · NA
Rectal Spacer Hydrogel Before Radiation Therapy in Reducing Radiation Dose to the Rectum in Patients With Prostate Cancer
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT05224869 is a NA study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 10 participants.
The verdict
NCT05224869, a NA study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
This phase II trial studies the effect of rectal spacer hydrogel before radiation therapy in reducing radiation dose to the rectum in patients with prostate cancer. Rectal spacer hydrogen is a soft gel material used to create a space between the rectum and prostate during radiation treatment. The rectal spacer gel is made up of 90% water and 10% polyethylene glycol and is injected as a liquid through a needle inserted between the rectum and prostate. It stays in place for about 3 months and is naturally absorbed into the body and removed through urine in about 6 months. By pushing the prostate further from the rectum with the hydrogel, it may help spare the rectum from receiving radiation during standard of care stereotactic body radiation therapy and brachytherapy treatment.
Interventions
- RADIATION Brachytherapy
- DEVICE Medical Device Usage and Evaluation
- PROCEDURE CT simulation
- PROCEDURE Stereotactic body radiation therapy
- PROCEDURE Post-implant dosimetry scan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-08-31 |
| Est. Completion | 2025-01-29 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05224869
The ClinicalTrials.gov registry entry for NCT05224869 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Brachytherapy is the first listed.
NCT05224869 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05224869 about?
NCT05224869 is a clinical study titled "Rectal Spacer Hydrogel Before Radiation Therapy in Reducing Radiation Dose to the Rectum in Patients With Prostate Cancer". This phase II trial studies the effect of rectal spacer hydrogel before radiation therapy in reducing radiation dose to the rectum in patients with prostate cancer. Rectal spacer hydrogen is a soft gel material used to create a space between the rectum and prostate during radiation treatment. The re...
What is the current status of trial NCT05224869?
This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2021-08-31. Estimated completion is 2025-01-29.
What interventions are being tested in trial NCT05224869?
The interventions under investigation include: Brachytherapy (RADIATION), Medical Device Usage and Evaluation (DEVICE), CT simulation (PROCEDURE), Stereotactic body radiation therapy (PROCEDURE), Post-implant dosimetry scan (PROCEDURE).
Who is sponsoring clinical trial NCT05224869?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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