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NCT02353832 · ClinicalTrials.gov registry record · Phase 2
Stereotactic Ablative Radiotherapy (SABR) for Low Risk Prostate Cancer With Injectable Rectal Spacer
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT02353832 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 44 participants.
The verdict
NCT02353832, a Phase 2 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
The purpose is to determine if use of rectal spacers are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects. It is also to determine whether it provides sufficient dosimetric benefits to warrant further clinical investigation in future SABR (Stereotactic Ablative Body Radiation) related clinical studies.
Interventions
- DEVICE Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2014-11-06 |
| Est. Completion | 2021-01-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02353832
The ClinicalTrials.gov registry entry for NCT02353832 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent) is the first listed.
NCT02353832 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02353832 about?
NCT02353832 is a clinical study titled "Stereotactic Ablative Radiotherapy (SABR) for Low Risk Prostate Cancer With Injectable Rectal Spacer". The purpose is to determine if use of rectal spacers are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects. It is also to determine whether it provides sufficient dosimetric benefits to warrant further clinic...
What is the current status of trial NCT02353832?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2014-11-06. Estimated completion is 2021-01-05.
What interventions are being tested in trial NCT02353832?
The interventions under investigation include: Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent) (DEVICE).
Who is sponsoring clinical trial NCT02353832?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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