Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Barrigel Injectable Gel, Cryoablation.
- Who it may be relevant to
- Registry conditions: Prostate Cancer (Diagnosis), Transperineal Cryoablation. Basic parameters: 40 years — 95 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR) Trial
Overview
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.
Interventions
- Device Barrigel Injectable Gel
Barrigel is a hyaluronic acid-based absorbable perirectal spacer. - Procedure Cryoablation
Minimally invasive treatment for both localized and recurrent prostate cancer.
Primary outcome measures
- Percentage of cases in which Barrigel remains unfrozen (temperature maintained above 0°C throughout the freeze cycles) [Time frame: End of procedure (up to 4 hours)]
Secondary outcome measures (6)
- Number of Barrigel-related complications post-procedure [Time frame: Visit 3 (6 months post-procedure)]
- Change in the greatest distance (mm) between the prostate gland and rectal wall pre- and post-procedural [Time frame: Visit 1 (Baseline), Visit 3 (6 months post-procedure)]
- Change from baseline in International Prostate Symptom Score (IPSS) [Time frame: Visit 1 (Baseline), Visit 2 (3 months post-procedure)]
- Change from baseline in Sexhual Health Inventory for Men (SHIM) score [Time frame: Visit 1 (Baseline), Visit 2 (3 months post-procedure)]
- Volume of Barrigel injected (mL) [Time frame: After administration (up to 1 hour)]
- Rectal wall separation achieved (mm) [Time frame: After administration (up to 1 hour)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07567027 · 25-01511