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FV-EUS Endoscope Versus CLA-EUS for EUS-FNA of Solid Lesions

NCT01673945 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2019-07-26

No results posted yet for this study

Summary

The intent of this study is to compare the performance of the CLA-EUS versus the FV-EUS in the performance of EUS-FNA of patients with solid lesions of the GI tract and of adjacent organs, with the aim of establishing for which lesions and from which location the capability of the FV-EUS will be superior, equal or, inferior to the CLA-EUS

Conditions

  • Solid Lesions of the GI Tract or of Adjacent Organs

Interventions

DEVICE

EUS-guided fine needle aspiration

Each patient will undergo examination with the CLA-EUS or the FV-EUS, which will be selected based on the randomization process. FV-EUS will be performed using the newly available FV -EUS scope (TGF-Y0001-UC) that is compatible with last generation Aloka alpha 10. First, search of the presumed lesion will be performed and once visualize, its characteristics (size, echogenicity, margins, etc) will be recorded on data collection sheet. Fine needle aspiration will be performed under EUS guidance using a 19- ,22- or a 25-gauge fine needle or procore needles depending on endoscopist's preference

Sponsors & Collaborators

  • University of Amsterdam

    collaborator OTHER

  • Erasme University Hospital

    collaborator OTHER

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Alberto Larghi, MD · Universita' del Sacro Cuore

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-07-31
Completion
2015-01-31

Countries

  • Belgium
  • Italy
  • Netherlands

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 NCT01673945 on ClinicalTrials.gov