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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07567027
Status
Recruiting
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Conditions

  • Prostate Cancer (Diagnosis)
  • Transperineal Cryoablation

Eligibility Criteria

Sex
MALE
Age
40 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
May 5, 2026
Start date
Jun 17, 2026
Status verified
Apr 2026
Primary completion
Dec 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Barrigel Placement
    Each subject will undergo transperineal ultrasound-guided Barrigel placement prior to their image-guided prostate cryoablation in the same procedure session.

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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