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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer (Diagnosis); Transperineal Cryoablation
• Intervention / Treatment: Device: Barrigel Injectable Gel; Procedure: Cryoablation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Viola Sulollari; Phone Number: (646) 825-6300; Email: Viola.Sulollari@nyulangone.org
• Study Contact Backup: Name: Wei Phin Tan, MD; Phone Number: 646-825-6325; Email: weiphin.tan@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Barrigel Placement; Each subject will undergo transperineal ultrasound-guided Barrigel placement prior to their image-guided prostate cryoablation in the same procedure session.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of cases in which Barrigel remains unfrozen (temperature maintained above 0°C throughout the freeze cycles)	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.	End of procedure (up to 4 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Barrigel-related complications post-procedure		Visit 3 (6 months post-procedure)
Change in the greatest distance (mm) between the prostate gland and rectal wall pre- and post-procedural		Visit 1 (Baseline), Visit 3 (6 months post-procedure)
Change from baseline in International Prostate Symptom Score (IPSS)	The International Prostate Symptom Score (IPSS) is a validated, 8-question self-assessment tool (7 symptom questions + 1 quality of life question) used to evaluate the severity of lower urinary tract symptoms (LUTS). Scores range from 0-35: Mild (0-7), Moderate (8-19), and Severe (20-35).	Visit 1 (Baseline), Visit 2 (3 months post-procedure)
Change from baseline in Sexhual Health Inventory for Men (SHIM) score	The SHIM Questionnaire (also known as the IIEF-5) is an abridged and slightly modified 5-item version of the 15-item International Index of Erectile Function (IIEF) designed for easy use by clinicians to diagnose the presence and severity of erectile dysfunction (ED) in clinical settings. Scores range from 5-25: Severe ED (5-7), Moderate ED (8-11), Mild to Moderate ED (12-16), Mild ED (17-21), and No ED (22-25)	Visit 1 (Baseline), Visit 2 (3 months post-procedure)
Volume of Barrigel injected (mL)		After administration (up to 1 hour)
Rectal wall separation achieved (mm)		After administration (up to 1 hour)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Wei Phin Tan, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: prostate; cryoablation; Barrigel
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Pathological Conditions, Signs and Symptoms; Prostatic Neoplasms; Disease; Surgical Procedures, Operative; Ablation Techniques; Cryosurgery
• Other Study ID Numbers: 25-01511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: weiphin.tan@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to weiphin.tan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes