NCT06249841

Feasibility of Cryobiopsy from the Bile Duct - CRYLEO

Feasibility of in Vivo Percutaneous Cryobiopsy from the Human Bile Duct - CRYLEO

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Erbe Elektromedizin GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	1.1mm flexible Cryoprobe SU	Six tissue samples retrieved by standard biopsy forceps and three samples by cryobiopsy (randomized sequence)

Timeline

• Start date: 2024-03-04
• Primary completion: 2024-08-30
• Completion: 2024-08-30
• First posted: 2024-02-08
• Last updated: 2025-01-24

Locations

5 sites across 1 country: Germany