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CLINICAL CLINICAL CLINICAL
CLINICAL CLINICAL CLINICAL

CLINICAL
RESULTS

Proven Safe & Effective At Reducing GI Toxicities

In patients undergoing radiation for prostate cancer.1

 

Clinically Proven

Optimal Protection for the rectum, reducing rectal side effects1

OVERVIEW OF RECTAL SPACER TRIALS1,4,6

OVERVIEW OF RECTAL
SPACER TRIALS1,4,6

Information provided for educational purposes only. No head-to-head study has been performed. 
Results from different clinical studies are not directly comparable.

RCT = Randomized Controlled Trial

* Dosimetric analysis was based upon 81 Gy in 1.8 Gy fractions.
** 2.3% (5 patients) missing primary safety results due to insufficient follow-up.
† In a separate, directly analogous secondary analysis of data from the Barrigel pivotal trial, Barrigel symmetry results were compared to those of SpaceOAR, as reported in Fischer-Valuck BW et al. Pract Radiat Oncol (2017), using the same methodology used in that study. Information provided for educational purposes only. No head-to-head study has been performed. Results from different clinical studies are not directly comparable.

Varun Sundaram, MD
When I talk to my patients about Barrigel, the biggest thing I like to focus on is the protection, as well as the very low rate of complications.
Varun Sundaram, MD
– Varun Sundaram, MD, Urologist, Urology Austin
This information reflects the personal experiences and professional medical opinions of the featured healthcare providers. Results may vary. All featured physicians are paid consultants of Teleflex.

Barrigel Pivotal Trial Overview & Results

TREATMENT PROTOCOL

TREATMENT
PROTOCOL

Hypofractionated radiation therapy (HFRT) – effective and more convenient

Radiation delivered with Hypofractionated regimen of 60gy 20 fractions (3 Gy/fraction)
Radiation delivered with Hypofractionated regimen of 60gy 20 fractions (3 Gy/fraction)

BENEFITS OF
HYPOFRACTIONATION

BENEFITS OF
HYPOFRACTIONATION

The utilization of HFRT has dramatically increased in recent years.7  While this modern form of radiation allows for higher doses given in fewer fractions, the rectum remains at risk for exposure. Given that HFRT has been associated with greater acute grade 2+ GI toxicity than conventionally fractionated radiation therapy (CFRT), rectal spacing may address a clinically important need for patients receiving HFRT.1

The Barrigel Pivotal Trial is the first and only FDA-reviewed randomized controlled study of rectal spacing that exclusively used hypofractionated radiation therapy.1,2

Neil Mariados, MD
There is a need for rectal spacing, even when radiation techniques have become more precise, because with these technique advances, we’ve also increased the dose given to patients over shortened, hypofractionated treatment schedules. And while greater dose means greater control and better outcomes, the prostate still remains very close to the rectum. So if we can increase that space, we also decrease the high dose to the rectum, thereby decreasing the toxicity.
Neil Mariados, MD
– Neil Mariados, MD, Radiation Oncologist
This information reflects the personal experiences and professional medical opinions of the featured healthcare providers. Results may vary.

EFFICACY MATTERS

EFFICACY MATTERS

Barrigel spacer is proven effective at achieving a clinically significant reduction in radiation dose to the rectum, leading to fewer rectal side effects1

In the Barrigel pivotal trial, 98.5% of patients met the primary endpoint of achieving at least a 25% reduction in rectal V54 Gy* (p<0.001)1

*54 Gy is 90% of 60 Gy

Barrigel rectal spacer is proven superior in the 
reduction of acute grade 2+ GI toxicity compared to control1

  • RADIATION PROCTITIS
  • DIARRHEA
  • HEMORRHOIDS
Barrigel spacer is proven superior in the reduction of acute and long-term grade 1+ GI toxicity compared to control1,2

SAFETY MATTERS

SAFETY MATTERS

In the Barrigel pivotal trial, there were:1

ZERO Barrigel spacer-related adverse events

ZERO Peri-procedural events

ZERO Reports of rectal fullness

ZERO Patient complaints of device-related pain or discomfort

Varun Sundaram, MD
The ability to control where the gel goes allows for a symmetric and significant distribution of gel at the apex, where radiation damage to the rectum is most likely to occur. This results in better rectal protection for the patient.
Varun Sundaram, MD
– Varun Sundaram, MD, Urologist, Urology Austin
This information reflects the personal experiences and professional medical opinions of the featured healthcare providers. Results may vary. All featured physicians are paid consultants of Teleflex.

ADVANCED CONTROL
OVER PLACEMENT1,3,8,9

ADVANCED CONTROL OVER
PLACEMENT1,3,8,9

 Information provided for educational purposes only. No head-to-head study has been performed. Results from different clinical studies are not directly comparable. 

BARRIGEL SPACER

BARRIGEL SPACER

Sculptable control over implant placement resulted in symmetric coverage from base to apex1,3,8-10

Implant Symmetry RESULTS3**  >95.6%

Pivotal Trial Patients; % of implants centered on prostate midline  

PEG HYDROGEL

PEG HYDROGEL

Lack of control over placement can result in uneven and inconsistent coverage that can impact dose reduction to the rectum3,5 

Implant Symmetry RESULTS5** >49%

Pivotal Trial Patients; % of implants centered on prostate midline

* Both rectal spacers were placed by the same physician.
** In a separate, directly analogous secondary analysis of data from the Barrigel pivotal trial, Barrigel symmetry results were compared to those of SpaceOAR, as reported in Fischer-Valuck BW et al. Pract Radiat Oncol (2017), using the same methodology used in that study. Information provided for educational purposes only. No head-to-head study has been performed. Results from different clinical studies are not directly comparable.

ACHIEVE CONSISTENT RESULTS
WITH BARRIGEL SPACER3,8,9

ACHIEVE CONSISTENT RESULTSWITH BARRIGEL
SPACER3,8,9

First Barrigel Spacer Cases - Consecutive Patients (Same Day)

Patient 1
15.26mm
Patient 2
10.25mm
Patient 3
14.64mm

TRUS images courtesy of Daniel R. Welchons, MD
Urologist; New York, United States

Results may vary.

DR. WELCHONS’ INJECTION TECHNIQUE

Daniel R. Welchons, MD
As a urologist new to spacing I found this procedure very easy to learn with great results. I know exactly where Barrigel is going during the procedure in real-time, so I have high confidence the spacing is adequate and safe.
Daniel R. Welchons, MD
– Daniel R. Welchons, MD, Principal Urologist, Associated Medical Professionals (AMP) of New York
This information reflects the personal experiences and professional medical opinions of the featured healthcare providers. Results may vary. All featured physicians are paid consultants of Teleflex.

IN RECTAL SPACING
STABILITY MATTERS

IN RECTAL SPACING STABILITY
MATTERS

Even as Barrigel spacer gradually resorbs, shape and separation are maintained, on average, through 3 months.1,3

PATIENT EXAMPLE SHOWING
STABLE SEPARATION DURING RESORPTION

hcp-clinical-studies--seperation-m1-2-1
hcp-clinical-studies--seperation-m2-2-1

Results may vary.

MEAN PROSTATE-RECTUM SEPARATION (DIMENSIONAL STABILITY)

clinically-proven--mean-seperation-m3

References

  • 1. Mariados NF, Orio PF III, Schiffman Z, et al, JAMA Oncol (2023).‡§ 

  • 2. Data on file. As of 4/01/2025.

  • 3. Svatos M, Chell E, Low DA et al. Med Phys (2024).‡§

  • 4. Mariados NF et al, Int J Radiat Oncol Biol Phys (2015). 

  • 5. Fischer-Valuck BW et al, Pract Radiat Oncol (2017).§ 

  • 6. Song D et al, Int J Radiat Oncol Biol Phys (2024).

  • 7. Dearnaley D, Syndikus I, Mossop H et al. Lancet Oncol (2016).

  • 8. Gejerman G, Goldstein MM, Chao M et al. Pract Radiat Oncol (2023).§ 

  • 9. Williams J, Mc Millan K, Chao M et al. J Med Imag Radiat Sci (2022).§

  • 10. King MT, Svatos M, Orio PF III et al. Pract Radiat Oncol (2023).‡§

  •  

    ‡ Study sponsored by Palette Life Sciences, now part  of Teleflex.

  • § One or more of the authors are paid consultants of Teleflex.

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