Recruiting

Barrigel

Sponsor:

NYU Langone Health

Code:

NCT07567027

Conditions

Prostate Cancer (Diagnosis)

Transperineal Cryoablation

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Barrigel Injectable Gel

Cryoablation

Study Details

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.

Conditions

Prostate Cancer (Diagnosis)

Transperineal Cryoablation

Study ID

NCT07567027

Start date

Jun 17, 2026

Status verified date

Apr, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Barrigel Placement

Each subject will undergo transperineal ultrasound-guided Barrigel placement prior to their image-guided prostate cryoablation in the same procedure session.

Interventions

Barrigel Injectable Gel

Barrigel is a hyaluronic acid-based absorbable perirectal spacer.

Cryoablation

Minimally invasive treatment for both localized and recurrent prostate cancer.

Primary outcome measure

  • Percentage of cases in which Barrigel remains unfrozen (temperature maintained above 0°C throughout the freeze cycles) [ Time Frame: End of procedure (up to 4 hours) ]

Central Contacts and Locations

Central contacts

Viola Sulollari

(646) 825-6300Viola.Sulollari@nyulangone.org

Wei Phin Tan, MD

646-825-6325weiphin.tan@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jul 9, 2026

Last verified

Apr, 2026

Keywords

  • cryoablation
  • prostate
  • Barrigel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-07-09.