Prostate Cancer (Diagnosis)NCT07567027
Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR)
A study testing Barrigel Injectable Gel and Cryoablation in people with Prostate Cancer (Diagnosis) and Transperineal Cryoablation, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 95 years, men only
- Conditions the study is for
- Prostate Cancer (Diagnosis), Transperineal Cryoablation
- What is being tested?
- Barrigel Injectable Gel and Cryoablation
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2026to 1 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 95 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: 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.
- Being tested
- Barrigel Injectable Gel, Cryoablation
- Keywords
- cryoablation, prostate, Barrigel
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barrigel Injectable GelDevice
Barrigel is a hyaluronic acid-based absorbable perirectal spacer.
CryoablationProcedure or surgery
Minimally invasive treatment for both localized and recurrent prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| Barrigel Placement | Experimental | Each subject will undergo transperineal ultrasound-guided Barrigel placement prior to their image-guided prostate cryoablation in the same procedure session. Receives: Device: Barrigel Injectable Gel; Procedure: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of procedure (up to 4 hours)
Secondary outcomes (6)
Number of Barrigel-related complications post-procedure
Measured: Visit 3 (6 months post-procedure)
Change in the greatest distance (mm) between the prostate gland and rectal wall pre- and post-procedural
Measured: 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).
Measured: 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)
Measured: Visit 1 (Baseline), Visit 2 (3 months post-procedure)
Volume of Barrigel injected (mL)
Measured: After administration (up to 1 hour)
Rectal wall separation achieved (mm)
Measured: After administration (up to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start17 Jun 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Phin Tan, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567027
- Sponsor's protocol ID
- 25-01511
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.