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CompletedNCT05718193Updated Apr 11, 2023

Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps

An interventional study of DeFrame and Classified DeFrame in Artificial Intelligence, Colonoscopy and Quality Control, sponsored by Xiangya Hospital of Central South University. Completed at 2 sites in China. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-11.

Sponsored by Xiangya Hospital of Central South University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jun 2022, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
2,868
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

To investigate the degree of the real-time detection and classification system for increasing the adenoma detection rate during colonoscopy.

02

Conditions studied

  • Artificial Intelligence
  • Colonoscopy
  • Quality Control
03

In context

Lead sponsor

Xiangya Hospital of Central South University is the lead sponsor of 170 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Aged 18 to 85 years old. Colonoscopies for primary CRC screening of the subjects are required.

Exclusion criteria

Exclusion Criteria:

History of CRC,inflammatory bowel disease, previous colonic resection, antithrombotic therapy precluding polyp resection.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
2,868 participants (actual)

Study arms

  • Experimental
    The DeFrame Group

    Subjects in the DeFrame group were treated with a real-time computer-aided polyp detection system named DeFrame during colonoscopy.

    Diagnostic Test: DeFrame

  • Experimental
    The Classified DeFrame Group

    Subjects in the Classified DeFrame group were treated with a real-time computer-aided polyp detection and classification system named Classified DeFrame during colonoscopy.

    Diagnostic Test: Classified DeFrame

  • Experimental
    The Control Group

    Subjects in the control group underwent standard colonoscopy.

    Diagnostic Test: conventional colonoscopy

Interventions

  • Diagnostic testDeFrame

    The DeFrame system is applicated during colonoscopy. The DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, notifying the endoscopists of the presence of the lesion.

  • Diagnostic testClassified DeFrame

    The Classified DeFrame system is applicated during colonoscopy. The Classified DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, the color of the rectangle box will turn blue when the polyp is considered as an adenoma, notifying the endoscopists of the presence of the lesion.

  • Diagnostic testconventional colonoscopy

    conventional colonoscopy

06

What researchers measure

Primary outcomes

  1. adenoma detection rate

    Percentage of patients who have 1 or more histologically confirmed adenoma resected divided by the total number of colonoscopies.

    Time frame: up to 9 months

  2. adenomas per colonoscopy

    Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.

    Time frame: up to 9 months

07

Study locations

2 sites
  • Xiangya Hospital Central South University
    Changsha, Hunan, China
  • Loudi Central Hospital
    Loudi, Hunan, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05718193
Lead sponsor
Xiangya Hospital of Central South University
Collaborators
Loudi Central Hospital
Responsible party
Sponsor
First posted
Feb 8, 2023
Start date
Jun 1, 2022
Primary completion
Feb 28, 2023
Completion
Mar 15, 2023
Last update
Apr 11, 2023

Study contacts

xiaowei liu, doctor
study director · Xiangya Hospital of Central South University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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