Health TrialsbyHealthPanel

Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR)

ConditionsProstate Cancer (Diagnosis)Transperineal Cryoablation
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Barrigel Injectable Gel

    Device

    Barrigel is a hyaluronic acid-based absorbable perirectal spacer.

  • Cryoablation

    Procedure/Surgery

    Minimally invasive treatment for both localized and recurrent prostate cancer.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Barrigel PlacementExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of cases in which Barrigel remains unfrozen (temperature maintained above 0°C throughout the freeze cycles)

Barrigel freeze will be defined as a measured temperature ≤ 0°C within or immediately adjacent to the gel, or ultrasound evidence of ice formation within the gel volume. Thermal stability will therefore be expressed as the percentage of procedures in which Barrigel resists freezing under standard cryoablation conditions.

Time frame
End of procedure (up to 4 hours)

Secondary outcomes

1

Number of Barrigel-related complications post-procedure

Time frame
Visit 3 (6 months post-procedure)
2

Change in the greatest distance (mm) between the prostate gland and rectal wall pre- and post-procedural

Time frame
Visit 1 (Baseline), Visit 3 (6 months post-procedure)
3

Change from baseline in International Prostate Symptom Score (IPSS)

The International Prostate Symptom Score (IPSS) is a validated, 8-question self-assessment tool (7 symptom questions + 1 quality of life question) used to evaluate the severity of lower urinary tract symptoms (LUTS). Scores range from 0-35: Mild (0-7), Moderate (8-19), and Severe (20-35).

Time frame
Visit 1 (Baseline), Visit 2 (3 months post-procedure)
4

Change from baseline in Sexhual Health Inventory for Men (SHIM) score

The SHIM Questionnaire (also known as the IIEF-5) is an abridged and slightly modified 5-item version of the 15-item International Index of Erectile Function (IIEF) designed for easy use by clinicians to diagnose the presence and severity of erectile dysfunction (ED) in clinical settings. Scores range from 5-25: Severe ED (5-7), Moderate ED (8-11), Mild to Moderate ED (12-16), Mild ED (17-21), and No ED (22-25)

Time frame
Visit 1 (Baseline), Visit 2 (3 months post-procedure)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Source ClinicalTrials.gov
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