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

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: Retrospective Study
• Intervention / Treatment: Diagnostic test: ESView software with proscan; Diagnostic test: Rapid software with SBI

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	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

• 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

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