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Improving Cryoablation for Prostate Cancer with Barrigel

This study, called ICE-BARR, is looking at how well Barrigel, a gel spacer, works to protect the rectum during cryoablation for prostate cancer. Cryoablation is a treatment that uses extreme cold to destroy cancer cells. Barrigel is injected between the prostate and the rectum to create space and protect the rectum from the cold. Researchers want to see if Barrigel stays unfrozen during the procedure, which would show it's protecting the rectum. You may be able to join if you are a man between 40 and 95 years old with localized prostate cancer (Grade Group ≥ 2), visible on an MRI, and a PSA level below 20 ng/ml. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 20 male participants. It is designed to evaluate the feasibility, safety, and protective benefit of Barrigel.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at the end of the procedure, up to 4 hours.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07567027

Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR)

Recruiting
NAAges 40–95InterventionalPrevention
NYU Langone Health
~20 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Barrigel Injectable GelCryoablation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of cases in which Barrigel remains unfrozen (temperature maintained above 0°C throughout the freeze cycles)
Measured over End of procedure (up to 4 hours)

Conditions

Prostate Cancer (Diagnosis)
Transperineal Cryoablation

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Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Wei Phin Tan, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Viola Sulollari
[email protected]
(646) 825-6300
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male patients aged 40-95 years.
Biopsy-confirmed localized prostate cancer (Grade Group ≥ 2). Salvage cryoablation cases may be included.
Unifocal disease visible on multiparametric MRI (mpMRI) and amenable to focal or whole gland cryoablation.
Prostate-specific antigen (PSA) \< 20 ng/ml.
No metastatic disease on Prostate-Specific Membrane Antigen (PSMA) PET/CT, when recommended per National Comprehensive Cancer Network (NCCN) guidelines.
Eligible for and consenting to transperineal cryoablation under anesthesia.
Willingness to comply with post-procedure follow-up, including PSA testing and imaging.
Cryoablation which requires treatment of the posterior prostate as per clinician judgement.

Exclusion

Evidence of metastatic disease.
Prior radiation therapy to the area of the prostate.
Active rectal or urinary tract infection.
Known allergy to hyaluronic acid products or contrast agents.
Inability to tolerate MRI.
Inability or unwillingness to comply with study follow-up.

What this trial measures

  • Percentage of cases in which Barrigel remains unfrozen (temperature maintained above 0°C throughout the freeze cycles)End of procedure (up to 4 hours)

    Barrigel freeze will be defined as a measured temperature ≤ 0°C within or immediately adjacent to the gel, or ultrasound evidence of ice formation within the gel volume. Thermal stability will therefore be expressed as the percentage of procedures in which Barrigel resists freezing under standard cryoablation conditions.