MedTrace Logo

Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract

NCT01770405 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2017-08-29

No results posted yet for this study

Summary

This study focuses on four different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract, pancreatic masses and GIST tumors.

On one hand, the results obtained during previous studies are more advanced for the assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have already been performed, and an interpretation criteria classification exists. On the other hand, results for pancreatic masses, Lymph nodes and GIST are less developed.

the objectives of the study are to

* Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract
* Define/Validate descriptive criteria of nCLE sequences in masses and cystic tu-mors of the pancreas, lymph nodes, submucosal lesions of the GI tract

Conditions

  • Pancreatic Cyst
  • Pancreatic Neoplasms
  • Pancreatic Adenoma
  • Pancreatic Cancer
  • Pancreatic Islet Cell Tumors
  • Lymph Node Mass
  • Lymphadenopathy
  • GIST

Interventions

DEVICE

Endoscopic ultrasound fine needle aspiration

Device: nCLE needle-based Confocal Laser Endomicroscopy

Sponsors & Collaborators

  • Mauna Kea Technologies

    lead INDUSTRY

Principal Investigators

  • Divyesh V Sejpal, MD · Northwell Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-12-21
Completion
2016-12-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01770405 on ClinicalTrials.gov