Custom coverage
for every patient

Now you can achieve patient-specific, custom coverage from apex to base through precise spacing made possible by the sculptable, non-polymerizing formulation of Barrigel, proven effective and safe in clinical trials.1

First FDA-reviewed randomized controlled study of

rectal spacing using hypofractionated radiotherapy (RT)1

Patients who met the primary endpoint

averaged AN 85% rectal V54 Gy reduction

(P<0.0001)1*

Superior to the Control for the
incidence of LONG-TERM Grade 2+
GI TOXICITY at 6 months

(P=0.0055)2

*54 Gy is 90% of 60 Gy.
In the Barrigel cohort, patients were injected with Barrigel and fiducials. In the control cohort, patients were injected with fiducials only.1

Section 1

Proven efficacy

Barrigel is proven effective at achieving a clinically significant reduction in radiation dose to the rectum in the Barrigel Prostate Trial1:

The hypofractionated regimen of radiation provided 60 Gy in
20 fractions (3 Gy/fraction)

98.5% of patients

met the primary endpoint of achieving at least

25% reduction in the rectal V54 Gy*

Patients who met the primary endpoint averaged an

85% reduction in the rectal V54 Gy*

3D rendering showing Barrigel being inserted between the prostate and rectum

The first FDA-reviewed rectal spacer proven to significantly reduce radiation delivered to the rectum during hypofractionated RT.1

*54 Gy is 90% of 60 Gy.

Section 2

Demonstrated safety

The clinical evidence from the study supports the safety of Barrigel1,2:

Barrigel was shown to be superior in the reduction of long-term Grade 2+ GI toxicity at 6 months compared to control

  • There were 4 (2.9%) Grade 2+ GI toxicities in the Barrigel cohort vs 9 (13.8%) in the control cohort (P=0.0055)

There were zero Barrigel-related adverse events

Section 3

Study design

The Barrigel Prostate Trial is the first FDA-reviewed randomized controlled study of rectal spacing with hypofractionated RT1:

  • In the trial, 201 adult patients diagnosed with up to unfavorable intermediate prostate cancer were randomized into 2 study cohorts, Barrigel (136) and control (65), and will be followed for 3 years
  • Radiation was delivered with a hypofractionated regimen of 60 Gy in 20 fractions (3 Gy/fraction)

*54 Gy is 90% of 60 Gy.

In the Barrigel cohort, patients were injected with Barrigel and fiducials. In the control cohort, patients were injected with fiducials only.1

Join the future
of rectal spacing

To start using Barrigel, request enrollment in
the Barrigel Training Program.

References
  1. Data from Palette Life Sciences 510(k) K220641.
  2. Data on file. Palette Life Sciences.