Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT04378660
Brief Summary:
Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy
Detailed Description:
This is an investigator-initiated multicentre non-randomized prospective interventional trial to validate the performance of a novel state-of-the-art computer-aided diagnostic (CAD) tool in polyp detection implemented as second observer during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. Patients referred for a screening surveillance or therapeutic colonoscopy will undergo a colonoscopy performed by an endoscopist with moderate to high adenoma detection rate (ADR \> 20% and \< 50%) while a second observer will follow the procedure on a bedside AI-tool to count the number of detections made by the AI system and categorize the results into positive or negative results as follows (1) true positive, (2) false negative, (3) other positive and (4) obvious false positive. When a doubtful detection is made by the AI-system, the second observer will ask to re-evaluate the indicated region. When the detection is clear, the endoscopist and second observer do not communicate. The entire procedure is recorded.
Study:
NCT04378660
Study Brief:
Protocol Section:
NCT04378660