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

NCT05308498 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 87

Last updated 2022-05-02

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

ESView software with proscan

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

DIAGNOSTIC_TEST

Rapid software with SBI

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • XiaoHua Hou · Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-03
Primary Completion
2022-03-28
Completion
2022-04-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05308498 on ClinicalTrials.gov