EUS GUIDED Transduodenal Biopsy Using the 19G Flex

NCT02307253 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2022-06-27

Study results available
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Summary

This study evaluates the feasibility, safety and accuracy of a 19 gauge (19G) needle in nitinol in the performance of endoscopic ultrasound (EUS) guided transduodenal biopsy for the acquisition of samples for histologic analysis. Patients with lesions that can be approached only from the duodenum will be prospectively enrolled.

Conditions

  • Abdominal Neoplasms

Interventions

DEVICE

Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)

EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Guido Costamagna, MD · Catholic University of the Sacred Heart

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States
  • France
  • Italy
  • Japan

Study Locations

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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 NCT02307253 on ClinicalTrials.gov