NCT07567027 Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR)
| NCT ID | NCT07567027 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Prostate Cancer (Diagnosis) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-06-17 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-06-17 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Wei Phin Tan, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT07567027 clinical trial?
This trial is open to male participants only, aged 40 Years or older, up to 95 Years, studying Prostate Cancer (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07567027 currently recruiting?
Yes, NCT07567027 is actively recruiting participants. Contact the research team at Viola.Sulollari@nyulangone.org for enrollment information.
Where is the NCT07567027 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07567027 clinical trial?
NCT07567027 is sponsored by NYU Langone Health. The principal investigator is Wei Phin Tan, MD at NYU Langone Health. The trial plans to enroll 20 participants.
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