Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07567027

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Cancer (Diagnosis) Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Transperineal Cryoablation Urogenital Diseases Urogenital Neoplasms

Age range

40 year–95 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Barrigel Injectable Gel

Device

Barrigel is a hyaluronic acid-based absorbable perirectal spacer.

Cryoablation

Procedure

Minimally invasive treatment for both localized and recurrent prostate cancer.

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. Number of Barrigel-related complications post-procedure

    Time frame: Visit 3 (6 months post-procedure)

  2. 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)

  3. Change from baseline in International Prostate Symptom Score (IPSS)

    Time frame: Visit 1 (Baseline), Visit 2 (3 months post-procedure)

    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).

  4. Change from baseline in Sexhual Health Inventory for Men (SHIM) score

    Time frame: Visit 1 (Baseline), Visit 2 (3 months post-procedure)

    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)

  5. Volume of Barrigel injected (mL)

    Time frame: After administration (up to 1 hour)

  6. Rectal wall separation achieved (mm)

    Time frame: After administration (up to 1 hour)

Study contacts

Contact information is provided by the study sponsor or research team.

Viola Sulollari

CONTACT

[email protected]

(646) 825-6300

Wei Phin Tan, MD

CONTACT

[email protected]

646-825-6325

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 5, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.