Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR)
Recruiting
N/A
Interventional Study
Prostate Cancer (Diagnosis)
Transperineal Cryoablation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 40 – 95
- Sex
- Male
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 20 (estimated)
- Sponsor
- NYU Langone Health · Other
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About This 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.
Trial Locations
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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 …
Contacts