Trial Outcomes & Findings for The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions (NCT NCT01431703)
NCT ID: NCT01431703
Last Updated: 2017-03-01
Results Overview
Recruitment status
COMPLETED
Target enrollment
326 participants
Primary outcome timeframe
For this training, patients were consecutively enrolled until a total of 45 target and non-target lesions were obtained.
Results posted on
2017-03-01
Participant Flow
Participant milestones
| Measure |
NBI With Magnification
Patients with lesions diagnosed by Sano classification using NBI with magnification
|
|---|---|
|
Overall Study
STARTED
|
326
|
|
Overall Study
COMPLETED
|
326
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions
Baseline characteristics by cohort
| Measure |
NBI With Magnification
n=326 Participants
Patients with lesions diagnosed by Sano classification using NBI with magnification
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
229 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
97 Participants
n=5 Participants
|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Gender
Female
|
131 Participants
n=5 Participants
|
|
Gender
Male
|
195 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
326 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: For this training, patients were consecutively enrolled until a total of 45 target and non-target lesions were obtained.Outcome measures
| Measure |
NBI With Magnification
n=326 Participants
Patients with lesions diagnosed by Sano classification using NBI with magnification
|
|---|---|
|
Accuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic Lesions
Accuracy
|
94.3 percentage of lesions
Interval 91.5 to 97.1
|
|
Accuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic Lesions
Sensitivity
|
98.0 percentage of lesions
Interval 94.3 to 99.9
|
|
Accuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic Lesions
Specificity
|
92.0 percentage of lesions
Interval 88.5 to 95.6
|
Adverse Events
NBI With Magnification
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place