MedTrace Logo

Feasibility of Cryobiopsy from the Bile Duct - CRYLEO

NCT06249841 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-01-24

No results posted yet for this study

Summary

This is a multi-center, prospective, feasibility study using a 1.1 mm flexible cryoprobe SU via percutaneous access in the bile duct. The device has a CE-approval. First feasibility and safety for application assessed in the bile duct performed ex vivo and in a patient case report study. The study will take place at 5 different sites in Germany. Recruitment is competitive. In total, 15 patients will be enrolled. Patients are screened for study inclusion at the participating hospitals.

Primary objective:

• Feasibility of percutaneous cryobiopsy in the bile duct

Secondary objectives:

* Size of biopsy (mean area (in mm2) of each biopsy technique)
* Percentage of successful retrievals of biopsies by each biopsy technique
* Representativeness of each biopsy sample
* Quality of each biopsy sample
* Grade of crash artifacts occurrence defined as crush artifact area per biopsy
* Rate of safety-relevant aspects, like for example bleeding, post-bleeding, perforation, infection and abscess

Conditions

  • Neoplasms, Bile Duct

Interventions

DEVICE

1.1mm flexible Cryoprobe SU

Six tissue samples retrieved by standard biopsy forceps and three samples by cryobiopsy (randomized sequence)

Sponsors & Collaborators

  • Erbe Elektromedizin GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2024-08-30
Completion
2024-08-30

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06249841 on ClinicalTrials.gov