Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR) Trial
NYU Langone Health
Summary
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.
Eligibility
- Age range
- 40–95 years
- Sex
- Male
- Healthy volunteers
- No
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 foll…
Interventions
- DeviceBarrigel Injectable Gel
Barrigel is a hyaluronic acid-based absorbable perirectal spacer.
- ProcedureCryoablation
Minimally invasive treatment for both localized and recurrent prostate cancer.
Location
- NYU Langone HealthNew York, New York