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

Recruiting now · Not applicable

Conditions studied: Prostate Cancer (Diagnosis), Transperineal Cryoablation

In brief

The purpose of this study is to evaluate the feasibility, safety, and potential protective benefit of Barrigel, a hyaluronic acid-based rectal spacer, in patients undergoing prostate cryoablation for localized or recurrent prostate cancer. The primary aim is to assess Barrigel thermal stability during cryoablation.

Key facts

Study ID

NCT07567027

Run by

NYU Langone Health

People needed

20

Starts

2026-06-17

Expected to finish

2028-06-01

Last updated by the study team

2026-07-09

Who can join

Age: 40 and older, up to 95. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• NYU Langone Health — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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