Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06496256
NA

Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

Sponsor: Palette Life Sciences, Inc.

View on ClinicalTrials.gov

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.

Official title: Randomized Trial of Barrigel® to Increase Distance Between the Rectum and Prostate Bed to Decrease Rectal Dose in Patients Receiving Moderately Hypofractionated Radiation Therapy Who Have Had Recurrence of Prostate Cancer After Prostatectomy

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2024-10-31

Completion Date

2027-12-31

Last Updated

2025-05-29

Healthy Volunteers

No

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

Locations (5)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Summit Health

Clifton, New Jersey, United States

Urology Austin

Austin, Texas, United States

Houston Metro Urology

Houston, Texas, United States

GenesisCare Ringwood

Melbourne, Victoria, Australia