Status:

COMPLETED

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

Lead Sponsor:

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

Conditions:

Retrospective Study

Eligibility:

All Genders

18+ years

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...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • N/A

Key Trial Info

Start Date :

March 3 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 10 2022

Estimated Enrollment :

87 Patients enrolled

Trial Details

Trial ID

NCT05308498

Start Date

March 3 2022

End Date

April 10 2022

Last Update

May 2 2022

Active Locations (1)

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

Wuhan, Hubei, China, 430000