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

NCT05308498 | Completed

• 1 other identifier: 102-CEP-0002
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retrospective Study

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

ESView software with proscan DIAGNOSTIC_TEST

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

ESView software with ProScan

Rapid software with SBI DIAGNOSTIC_TEST

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

Rapid software with SBI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

Study Officials

• XiaoHua Hou

  Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: April 4, 2022
• Study Start: March 3, 2022
• Primary Completion: March 28, 2022
• Study Completion: April 10, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)