User's Manual

NaviCam Small Bowel Capsule Endoscopy System
User Manual P a g e |
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ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1
capsule or comparator) for the diagnosis of small bowel diseases.
Study primary endpoints included Per Findings analysis, where the recordings obtained with
both capsules were independently evaluated and the agreement between findings of both
capsules was evaluated; and, Per Subject analysis; where the diagnosis of subjects based on
independent interpretation of images obtained with both capsules was evaluated (diagnosis of
normal or abnormal per subject). A number of secondary endpoints were also assessed
including ease of swallowing the capsule, intestinal transit time, capsule excretion time,
diagnostic yield when compared to other standard mucosal imaging procedures, quality of small
bowel images, image reading time, and agreement between two or more reviewers with respect
to interpretation of the images obtained.
The study included adult subjects with symptoms of small bowel diseases or suspected
gastrointestinal bleeding. After signing informed consent, subjects who met the study eligibility
criteria completed gastrointestinal preparation in advance according to the examination
schedule. Before swallowing the capsules, an antifoaming agent (10ml simethicone) with 120ml
of water was administered to reduce air bubble formation in the small bowel. Each subject wore
the two types of data recorders then swallowed the two types of small bowel capsules
approximately 40 minutes apart in a randomized order. Subjects were allowed to drink water 2
hours after swallowing the capsules and eat a small amount of food 4 hours after swallowing the
capsules. Upon confirming that the capsules have entered the small bowel, the subjects left the
hospital and were instructed to continue wearing the data recorders for 8-10 hours until the
power of the capsules were depleted, or the capsules were excreted.
The anonymized images acquired by both the trial capsule and comparator were read by two
gastroenterologists independently for normal and abnormal interpretation and analysis of lesion
type (edema, polyp, hemorrhage, etc.), capsule transit time, reading time and image quality; in
cases of disagreement, a third gastroenterologist reviewed the video in question and provided
his/her result.
A total of 97 subjects were enrolled in the study; 10 subjects were withdrawn or withdrew
consent prior to the study procedure. As these subjects did not swallow the capsules, they were
excluded from data analysis, therefore, the results from 87 subjects were included in both Per
Protocol Set (PPS) analysis and Full Analysis Set (FAS).
Primary Efficacy Results:
Per Subject Analysis: Normal versus Abnormal
Abnormal rates (NaviCam 73/87 – PillCam 68/87) 83.91% – 78.16%,
Positive Percent Agreement (PPA) [95% CI]: 97.06% (89.90%, 99.19%)
Negative Percent Agreement (NPA) [95%CI] 63.16% (41.04%, 80.85%)
Overall Percent Agreement [95% CI] 89.66% (81.50%, 94.46%)
Overall percent agreement per Kappa analysis [95% CI] 0.6652 (0.4653, 0.8652)
Positive Predictive Value (PPV) [95% CI] 90.41% (81.50%, 95.28%)
Negative Predictive Value (NPV) [95% CI] 85.71% (60.06%, 95.99%)
McNemar Test Results X2=2.7778, p=0.0956