Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR)
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2026
CompletedFirst Posted
Study publicly available on registry
May 5, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
Study Completion
Last participant's last visit for all outcomes
June 1, 2028
May 5, 2026
April 1, 2026
1.5 years
April 28, 2026
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
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)
Visit 1 (Baseline), Visit 2 (3 months post-procedure)
Change from baseline in Sexhual Health Inventory for Men (SHIM) score
Visit 1 (Baseline), Visit 2 (3 months post-procedure)
Volume of Barrigel injected (mL)
After administration (up to 1 hour)
- +1 more secondary outcomes
Study Arms (1)
Barrigel Placement
EXPERIMENTALEach subject will undergo transperineal ultrasound-guided Barrigel placement prior to their image-guided prostate cryoablation in the same procedure session.
Interventions
Barrigel is a hyaluronic acid-based absorbable perirectal spacer.
Minimally invasive treatment for both localized and recurrent prostate cancer.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Phin Tan, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2026
First Posted
May 5, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.