Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 1, 2027 → Dec 1, 2028
See other at-risk trials from Palette Life Sciences, Inc.

Record History

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  1. Primary completion pushed from Dec 1, 2027 to Dec 1, 2028 Show 4 more changesShow less
    • Trial sites expanded: 5 → 13 locations
    • Study completion pushed from Dec 31, 2027 to Dec 31, 2028
    • Secondary endpoints: details revised at 2 of 3 entries
    • Eligibility criteria expanded, about 3 words
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 5
    • Start date changed from estimate of Aug 5, 2024 to Oct 31, 2024
    • Secondary endpoints: details revised at 2 of 3 entries
    v3
  3. Secondary endpoints revised (3)v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Barrigel is intended to temporarily position the anterior rectal wall away from the prostate or prostate bed during radiotherapy treatment for prostate cancer and, in creating this space, it is the intent of Barrigel to reduce the radiation dose delivered to the anterior rectum.
Trial Details
NCT Number NCT06496256
Lead Sponsor Palette Life Sciences, Inc.
Collaborators: Teleflex
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov