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NCT01770405 · ClinicalTrials.gov registry record
Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract
A clinical trial of Pancreatic Cancer and Pancreatic Neoplasms, sponsored by Mauna Kea Technologies.
- Completed
- Registry status
- 40
- Enrollment target
- 4
- Study locations
NCT01770405: Completed study of Pancreatic Cancer and Pancreatic Neoplasms, sponsored by Mauna Kea Technologies.
NCT01770405 is a study of Pancreatic Cancer and Pancreatic Neoplasms that has completed, run by Mauna Kea Technologies. The registered enrollment target is 40 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01770405, a study of Pancreatic Cancer and Pancreatic Neoplasms, has completed, sponsored by Mauna Kea Technologies.
- COMPLETED
- Registry status
- 40 participants
- Enrollment target
- 4
- Study locations
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
Primary Outcome
* 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 (accuracy evaluation) * Define/Validate descriptive criteria for nCLE sequences in the characterization of masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract (image interpretation criteria definition
Conditions Studied
Interventions
- DEVICE Endoscopic ultrasound fine needle aspiration
Study Locations (4)
New York
- North Shore-LIJ Health System - Manhasset
- Columbia University Medical Center - New York
Georgia
- Emory University Hospital - Atlanta
Pennsylvania
- Temple University Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-12-21 |
What the finished NCT01770405 record still lists
NCT01770405 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (90% lower).
The record links to 8 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 1 intervention - of which Endoscopic ultrasound fine needle aspiration is the first listed.
NCT01770405 reports a single indexed study location in New York, Georgia, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01770405 about?
NCT01770405 is a clinical study titled "Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract". 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 Conf...
What is the current status of trial NCT01770405?
This trial is currently completed. The enrollment target is 40 participants. The study started on 2013-09. Estimated completion is 2016-12-21.
What conditions does trial NCT01770405 study?
This clinical trial studies the following conditions: Pancreatic Cancer, Pancreatic Neoplasms, Pancreatic Cyst, GIST, Lymphadenopathy.
What interventions are being tested in trial NCT01770405?
The interventions under investigation include: Endoscopic ultrasound fine needle aspiration (DEVICE).
Who is sponsoring clinical trial NCT01770405?
This trial is sponsored by Mauna Kea Technologies, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01770405 being conducted?
This trial has 4 study locations across Georgia, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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