Clinical trialNACompleted
In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors
- Outcome
- Outcome unknown
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- July 2010
- Expected end
- May 2012
- Enrollment
- 66 participants
- Sites
- 1
- Primary outcomes
- Sensitivity; Specificity; PPV (Positive Predictive Value); NPV (Negative Predictive Value)
- Sponsor
- Other
- Results posted
- 2015-03-31
- Last update
- 8 June 2016
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Brief summary public domain (ClinicalTrials.gov)
Assess the safety and efficacy of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in differentiating benign from malignant and premalignant cysts (e.g. mucinous from non-mucinous cysts)
Detailed description public domain (ClinicalTrials.gov)
The primary aim of the study is to define interpretation criteria to differentiate mucinous from non-mucinous cysts and classify more precisely the cysts. Once these criteria have been defined, the diagnostic parameters of nCLE in differentiating the different types of cysts and the reproducibility of these criteria will be assessed.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Sensitivity [October 2011]. Number, percentage of participants (95% Confidence Interval). nCLE System (Stage 2) (n=31): 59 (36 to 79).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Complication Rate [August 2011]. Number, percentage of participants (95% Confidence Interval). nCLE System (n=66): 9 (3 to 19).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Specificity [October 2011]. Number, percentage of participants (95% Confidence Interval). nCLE System (Stage 2) (n=31): 100 (66 to 100).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
PPV (Positive Predictive Value) [October 2011]. Number, percentage of participants (95% Confidence Interval). nCLE System (Stage 2) (n=31): 100 (75 to 100).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
NPV (Negative Predictive Value) [October 2011]. Number, percentage of participants (95% Confidence Interval). nCLE System (Stage 2) (n=31): 50 (26 to 74).