Retrospective Evaluation to Compare AKE-1 (Navicam SB) Capsule Endoscope System and PillCam SB3 Capsule System
- Conditions
- Retrospective Study
- Interventions
- Diagnostic Test: Rapid software with SBIDiagnostic Test: ESView software with proscan
- Registration Number
- NCT05308498
- Lead Sponsor
- Wuhan Union Hospital, China
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
- 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.
- N/A
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Rapid software with SBI 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 ESView software with ProScan 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
- Primary Outcome Measures
Name Time Method Diagnostic consistency 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China