Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

7. juli 2026 opdateret af: NYU Langone Health

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10016
        • Rekruttering
        • NYU Langone Health

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Barrigel Placement
Each subject will undergo transperineal ultrasound-guided Barrigel placement prior to their image-guided prostate cryoablation in the same procedure session.
Enhed: Barrigel Injectable Gel
Barrigel is a hyaluronic acid-based absorbable perirectal spacer.
Procedure: Cryoablation
Minimally invasive treatment for both localized and recurrent prostate cancer.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of cases in which Barrigel remains unfrozen (temperature maintained above 0°C throughout the freeze cycles)
Tidsramme: End of procedure (up to 4 hours)
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.
End of procedure (up to 4 hours)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Barrigel-related complications post-procedure
Tidsramme: Visit 3 (6 months post-procedure)
Visit 3 (6 months post-procedure)
Change in the greatest distance (mm) between the prostate gland and rectal wall pre- and post-procedural
Tidsramme: Visit 1 (Baseline), Visit 3 (6 months post-procedure)
Visit 1 (Baseline), Visit 3 (6 months post-procedure)
Change from baseline in International Prostate Symptom Score (IPSS)
Tidsramme: Visit 1 (Baseline), Visit 2 (3 months post-procedure)
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).
Visit 1 (Baseline), Visit 2 (3 months post-procedure)
Change from baseline in Sexhual Health Inventory for Men (SHIM) score
Tidsramme: Visit 1 (Baseline), Visit 2 (3 months post-procedure)
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)
Visit 1 (Baseline), Visit 2 (3 months post-procedure)
Volume of Barrigel injected (mL)
Tidsramme: After administration (up to 1 hour)
After administration (up to 1 hour)
Rectal wall separation achieved (mm)
Tidsramme: After administration (up to 1 hour)
After administration (up to 1 hour)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

NYU Langone Health

Efterforskere

  • Ledende efterforsker: Wei Phin Tan, MD, NYU Langone Health

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. juni 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25-01511

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: weiphin.tan@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

IPD-delingstidsramme

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD-delingsadgangskriterier

The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to weiphin.tan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner