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

NCT07567027 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Prostate Cancer (Diagnosis)
  • Transperineal 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.

Sponsors & Collaborators

Principal Investigators

  • Wei Phin Tan, MD · NYU Langone Health

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
95 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-12-01
Completion
2028-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07567027 on ClinicalTrials.gov