Clinical trial · Observational
Retrospective Evaluation of a Commercially Available Hydrogel Spacer (BP-009)
Clinical Protocol for the Retrospective Evaluation of a Commercially Available Hydrogel Spacer
NCT05423431CI-TRIAL-00059305completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Dosimetry efficacy of the hydrogel spacer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Radiation with Hydrogel Spacer
- description
- Males at least 18 years of age, who underwent radiation therapy with a hydrogel spacer in place.
- interventionNames
- Other: Observation
Primary outcomes (1)
- measure
- Dosimetry Changes
- timeFrame
- 1 Month
- description
- Assessment of rectal radiation exposure as compared between rectal dose volume histograms calculated for pre and post hydrogel injection
Secondary outcomes (1)
- measure
- Prostate to rectum spacing
- timeFrame
- 1 Month
- description
- Prostate to rectum spacing as measured post hydrogel insertion based on CT simulation scans done after hydrogel insertion
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males * At least 18 years of age * Undergone external beam or brachy radiation therapy with a hydrogel spacer in place Exclusion Criteria: * Clinical and pathological data are not available * Invasive adenocarcinoma that is extracapsular and demonstrates posterior extension
References
Publications (0)
Data not yet available
No reference posted for this study.