Efficacy of Artificial Intelligence-assisted Colonic Polyp Detection System

• Sponsor: Xiangya Hospital of Central South University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05941689
• Collaborator: (none)
• Enrollment: 2,000
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 2.2
• Patients Per Site: 1000
• Patients Per Site Per Month: 454.3

Study Details

Study Description

Brief Summary

This is a randomized controlled multicenter clinical trial of computer-aided detection (CADe) system for the adjuvant diagnosis of intestinal polyps/adenomas ever conducted in a Chinese population. In addition, this study will evaluate the effect of CADe system on adenoma detection of endoscopists under fatigue.

Condition or Disease	Intervention/Treatment	Phase
Adenoma Colon	Device: AI-assisted colonoscopy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Research on the Auxiliary Diagnosis and Treatment System of Digestive Endoscopy Based on Artificial Intelligence: An Efficacy Study of Artificial Intelligence-assisted Colonic Polyp Detection System
• Anticipated Study Start Date: Jul 25, 2023
• Anticipated Primary Completion Date: Sep 20, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AI-assisted group Subjects in this group undergo AI-assisted colonoscopy. The AI-assisted system not only has the function of automatic polyp detection, but also has the function of colonoscopy quality control.	Device: AI-assisted colonoscopy; AI can not only detect suspicious lesions timely, and label them in the field of view of the colonoscopy, but also monitor withdrawal speed and calculate the clean withdrawal time automatically.
No Intervention: control group Subjects in this group undergo routine colonoscopy.

Outcome Measures

Primary Outcome Measures

1. adenoma detection rate [up to 2months]

   The proportion of patients with at least one histologically proven adenoma or carcinoma

2. withdrawal time compliance rate [up to 2months]

   The proportion of patients with clean withdrawal time >6min.

Secondary Outcome Measures

1. polyp detection rate [up to 2 months]

   The proportion of patients with at least one polyp.

2. adenoma per colonoscopy [up to 2 months]

   The number of adenomas detected per colonoscopy

3. polyp per colonoscopy [up to 2 months]

   The number of polys detected per colonoscopy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:Patients who need to undergo colonoscopy. -

Exclusion Criteria:Patients with CRC, inflammatory bowel disease, previous colonic resection, and antithrombotic therapy precluding polyp resection were excluded.

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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xiangya Hospital Central South University	Changsha	Hunan	China
2	Loudi Central Hospital	Loudi	Hunan	China

Sponsors and Collaborators

• Xiangya Hospital of Central South University

Investigators

• Principal Investigator: Xiaowei Liu, doctor, Xiangya Hospital of Central South University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiangya Hospital of Central South University
• ClinicalTrials.gov Identifier: NCT05941689
• Other Study ID Numbers: 202306499
• First Posted: Jul 12, 2023
• Last Update Posted: Jul 12, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Adenoma; Colonic Polyps

Study Results

No Results Posted as of Jul 12, 2023