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NCT01392274 · ClinicalTrials.gov registry record

pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture

A clinical trial, sponsored by Mauna Kea Technologies.

Completed
Registry status
121
Enrollment target

NCT01392274: Completed study, sponsored by Mauna Kea Technologies.

NCT01392274 is a clinical trial that has completed, run by Mauna Kea Technologies. The registered enrollment target is 121 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01392274 has completed, sponsored by Mauna Kea Technologies.

COMPLETED
Registry status
121 participants
Enrollment target

Study Summary

This study will collect data from patients undergoing an ERCP procedure with probe-based Confocal Laser Endomicroscopy for suspicion of bile duct cancer. the objective is to evaluate the diagnostic performance of pCLE for the diagnosis of indeterminate biliary stricture when associated with other diagnostic information (standard ERCP and tissue sampling).

Primary Outcome

Evaluation of pCLE diagnostic performance for the diagnosis of indeterminate biliary stricture (ie. number of patients accurately diagnosed) when associated with other diagnostic information The following calculations will be conducted: sensitivity, specificity, positive and negative predictive values, Accuracy

Trial Details

FieldValue
Enrollment Target 121 participants
Start Date 2012-04
Est. Completion 2013-09
Mauna Kea Technologies

6 total trials

What the finished NCT01392274 record still lists

NCT01392274 is an observational study that tracks outcomes without assigning an intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT01392274 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01392274 about?

NCT01392274 is a clinical study titled "pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture". This study will collect data from patients undergoing an ERCP procedure with probe-based Confocal Laser Endomicroscopy for suspicion of bile duct cancer. the objective is to evaluate the diagnostic performance of pCLE for the diagnosis of indeterminate biliary stricture when associated with other di...

What is the current status of trial NCT01392274?

This trial is currently completed. The enrollment target is 121 participants. The study started on 2012-04. Estimated completion is 2013-09.

Who is sponsoring clinical trial NCT01392274?

This trial is sponsored by Mauna Kea Technologies, which has 6 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01392274, the US trial registry maintained by the National Library of Medicine. NCT01392274 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.