NCT07567027Recruiting
Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR)
Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR) Trial
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 28 Apr 2026
- Start date
- 17 Jun 2026
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- NYU Langone Health
- Diseases
- Prostate cancer
- NCT number
- NCT07567027
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 17 Jun 2026 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiation therapy to the area of the prostate.
Other illness
- Evidence of metastatic disease.
- Active rectal or urinary tract infection.
- Known allergy to hyaluronic acid products or contrast agents.
Other
- Inability to tolerate MRI.
- Inability or unwillingness to comply with study follow-up.
Who the study is looking for
- 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.
Age in the registry: 40 years to 95 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.