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Novel Crown-cut Biopsy Needle (FNB) vs Standard Aspiration Needle (FNA) for EUS-guided Diagnosis of SPLs

NCT04687410 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2020-12-29

No results posted yet for this study

Summary

The aim of this study is to compare tissue quality and molecular yield between a novel crown-cut biopsy needle (FNB) and a standard aspiration needle (FNA) for EUS-guided diagnosis of solid pancreatic lesions.

Conditions

  • Pancreas Neoplasm
  • Pancreas Cancer

Interventions

DEVICE

ProControl, MediGlobe

standard 22G FNA needle

DEVICE

TopGain, Medi-Globe

novel 22G crown-cut FNB needle

Sponsors & Collaborators

  • Gastro Unit, Endoscopy Section, Hvidovre Hospital, Denmark

    collaborator UNKNOWN

  • Department of Gastroenterology, Ponderas Academic Hospital Bucharest, Romania

    collaborator UNKNOWN

  • Endoscopy Unit, Odense Hospital, Denmark

    collaborator UNKNOWN

  • Peter Vilmann MD, DSc, HC, FASGE

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2021-04-01
Completion
2021-06-01

Countries

  • Denmark

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 NCT04687410 on ClinicalTrials.gov