Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-95
SponsorNYU Langone Health
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Barrigel Injectable Gel
- Cryoablation
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
1NYU Langone Health10016, New YorkNew York, United States
Sponsors and collaborators
NYU Langone Health
Lead sponsor
Source ClinicalTrials.gov