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

April 25, 2022 updated by: Wuhan Union Hospital, China

Retrospective Evaluation to Compare Small Bowel Video Reading by AKE-1 (Navicam SB) Capsule Endoscope System With and Without ProScan Module and PillCam SB3 Capsule System With SBI

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: ESView software with proscan
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
Diagnostic test: Rapid software with SBI
Each reviewer will review random video and record all lesions/findings with the PillCam Rapid software with SBI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic consistency
Time Frame: 1 month
The agreement rate between ESView software with ProScan assisted reading mode in the AKE-1 system and Rapid software with SBI pre-selection mode in the PillCam SB3 system on video classification, i.e. normal or abnormal.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Investigators

  • Principal Investigator: XiaoHua Hou, Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 3, 2022

Primary Completion (ACTUAL)

March 28, 2022

Study Completion (ACTUAL)

April 10, 2022

Study Registration Dates

First Submitted

March 6, 2022

First Submitted That Met QC Criteria

April 1, 2022

First Posted (ACTUAL)

April 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 102-CEP-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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