MedTrace Logo

Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

NCT06496256 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-05-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Barrigel

Barrigel is an absorbable gel based on Non-Animal Stabilized Hyaluronic Acid (NASHA™) that is injected into the peri-rectal space

DEVICE

Transrectal Ultrasound

All subjects will have a transrectal ultrasound (TRUS) conducted. In the control subjects this will act as a sham procedure. For the investigational subjects, the TRUS will be used to visualize the placement of the needle

Sponsors & Collaborators

  • Teleflex

    collaborator INDUSTRY

  • Palette Life Sciences, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2027-12-01
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06496256 on ClinicalTrials.gov