Retrospective Evaluation to Compare AKE-1 (Navicam SB) Capsule Endoscope System and PillCam SB3 Capsule System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-03

Study Completion Date

2022-04-10

Brief Summary

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This is a retrospective study on prospectively collected patient video data from a multicenter, single-blinded pivotal trial (Ethics Approval No. \[2021\] (0635-01)), involving a consecutive series of patients recruited by 3 Chinese centers based on the suspected small bowel disease, gastrointestinal bleeding, etc. All video images will be anonymized (de-identified). Video images from both the investigational device and comparator device are reviewed by two independent reviewers. Once the conventional reading has been completed, each reviewer will then review randomized videos with the ProScan feature enabled in ESView or SBI enabled on the Pillcam Rapid software. Each reviewer should review for normal versus abnormal findings, type of visual findings and categorization (lesions, polyps, bleeding, etc.), diagnosis, reading time, and subjective assessment of visual quality.

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Detailed Description

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This is a retrospective study on prospectively collected patient video data from a multicenter, single-blinded pivotal trial, involving a consecutive series of patients recruited by 3 Chinese centers based on the suspected small bowel disease, gastrointestinal bleeding, etc.

Video images from both the investigational device and comparator device are reviewed by two independent reviewers. Video that will be retrospectively collected, have been anonymized. Each reviewer will review the images collected according to the "conventional reading" as recommended by ACG guidelines.

Once the conventional reading has been completed, each reviewer will then review randomized videos with the ProScan feature enabled in ESView or SBI enabled on the Pillcam software . Each reviewer will then review the videos and document all lesions/findings found by the ProScan and Pillcam software with SBI. Annotations should be done after the reading, each finding shall be labelled and categorized (active bleeding, Angioectasia, polyps/ nodules, tumors or varisces, ulcers, isolated erosions, lesions, other).

For all lesions/findings, if there was significant disagreement between two reviewers for the same image, for both capsule videos, another independent reviewer will then review the video of that examination and provide his review results.

Conditions

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Retrospective Study

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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ESView software with ProScan

evaluate the performance of the NaviCam SB Capsule System ProScan software feature in comparison with the PillCam SB3 Capsule system SBI feature

ESView software with proscan

Intervention Type DIAGNOSTIC_TEST

Each reviewer will review random video and record all lesions/findings with the ESView software with ProScan.

Rapid software with SBI

evaluate the performance of the NaviCam SB Capsule System ProScan software feature in comparison with the PillCam SB3 Capsule system SBI feature

Rapid software with SBI

Intervention Type DIAGNOSTIC_TEST

Each reviewer will review random video and record all lesions/findings with the PillCam Rapid software with SBI.

Interventions

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ESView software with proscan

Each reviewer will review random video and record all lesions/findings with the ESView software with ProScan.

Intervention Type DIAGNOSTIC_TEST

Rapid software with SBI

Each reviewer will review random video and record all lesions/findings with the PillCam Rapid software with SBI.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients who participated in the study titled Performance Evaluation of the NaviCam SB Capsule Endoscope System in Comparison to the PillCam SB3 Capsule System for the Diagnosis of Small Bowel Diseases (Ethics Approval No. \[2021\] (0635-01)) and were included in the FAS.