Artificial-intelligence-based Reporting Technology for Endoscopy Monitoring and Imaging System

NCT06094270 | Completed

• 1 other identifier: AI03
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

Properly documenting withdrawal time in colonoscopy is essential for quality assessment and cost allocation. However, reporting withdrawal time has significant interobserver variability. Additionally, current manual documentation of endoscopic findings is time-consuming and distracting for the physician. This trial examines an artificial intelligence based system to determine withdrawal time and create a structured report, including high-quality images (AI) of detected polyps and landmarks.

Conditions

Colonoscopy

Keywords

Withdrawal Time; Medical Report; Colonoscopy; Artificial Intelligence; Endoscopy

Outcome Measures

Primary Outcomes (1)

• Withdrawal time error comparison for colonoscopies using the proposed AI system versus physician estimation

  The error between gold standard withdrawal time and the withdrawal time estimated from the proposed AI system and the physician are compared for the same examination.

  Through study completion, an average of 5 months

Secondary Outcomes (3)

• Image quality satisfaction

  Through study completion, an average of 5 months

• Subgroup analysis for withdrawal time calculation error based on the presence or absence of resections in the examination.

  Through study completion, an average of 5 months

• Number of examination where withdrawal time could not be determined

  Through study completion, an average of 5 months

Study Arms (1)

Experimental: Intervention arm

All patients within the study are included in the intervention arm: The withdrawal time for the interventions for all patients is documented by the physician and the proposed AI system.

Device: EndoMind

Interventions

EndoMind DEVICE

Withdrawal time is calculated and an image report is generated using the EndoMind system.

Experimental: Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (\>18 years) scheduled for screening, surveillance, or diagnostic colonoscopy

You may qualify if:

• Adult patients (\>18 years)
• Scheduled for colonoscopy

You may not qualify if:

• Patient / Examination level
• Inflammatory Bowel Disease
• Familial Polyposis Syndrome
• Patient after radiation/resection of colonic parts
• Data level
• Endoscopic recordings started after beginning of withdrawal.
• Examination recordings stopped before the end of the examination.
• Examinations with corrupt video signal

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: October 23, 2023
• Study Start: December 19, 2023
• Primary Completion: March 27, 2024
• Study Completion: March 27, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)