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Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR)
Recruiting
Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR) Trial
Who can join
Ages 40 to 95 · Men
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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.
About the study
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.
What is being tested
- Barrigel Injectable Gel (device)
- Cryoablation (procedure)
Sponsor: NYU Langone Health · Participants: 20 · Started: Jun 17, 2026
Contact the study team
- Viola Sulollari · Phone: (646) 825-6300
- Wei Phin Tan, MD · Phone: 646-825-6325
Official record on ClinicalTrials.gov — NCT07567027
Locations in the U.S.
| New York | NYU Langone Health, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.