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CompletedNCT05687318Updated Sep 6, 2023

A Clinical Trial of the Effectiveness and Safety of Software Assisting Diagnose the Intestinal Polyp Digestive Endoscopy by Analysis of Colonoscopy Medical Images From Electronic Digestive Endoscopy Equipment

An interventional study of DeFrame in Artificial Intelligence, Enteroscope and Intestinal Polyposis, Adenomatous, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-06.

Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2022, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
337
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

A clinical trial of the effectiveness and safety of intestinal polyp digestive endoscopy-assisted diagnosis software used in the analysis of colonoscopy medical images generated by electronic digestive endoscopy equipment.

02

Conditions studied

  • Artificial Intelligence
  • Enteroscope
  • Intestinal Polyposis, Adenomatous
03

In context

Adenomatous Polyposis Coli

90 studies on the registry are indexed under Adenomatous Polyposis Coli; 28 are open to participants now.

This study's enrollment of 337 is above the median of 43 across 60 interventional studies indexed under Adenomatous Polyposis Coli.

Browse Adenomatous Polyposis Coli studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 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

  • Age of 18 to 85 years old, regardless of gender;
  • electronic colonoscopy is required;
  • The subjects or their legal representatives could understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent.

Exclusion criteria

Exclusion Criteria:

  • (1) Contraindications associated with electronic colonoscopy or biopsy;
  • (2) poor intestinal preparation;
  • (3) diagnosed colorectal cancer, familial polyposis, or complicated with known colorectal polyps;
  • (4) serious neurological diseases or dysfunction of vital organs (heart, lung, liver, kidney);
  • (5) acute abdominal or intestinal inflammation;
  • (6) History of abdominal, pelvic, anal and perianal operations within 2 months before enrollment;
  • (7) Participated in other interventional clinical trials within 1 month before enrollment;
  • (8) In the interest of subjects, the investigator considers that they should not participate in other conditions of the clinical trial.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
337 participants (actual)

Study arms

  • Experimental
    Trial Ⅰ

    Subjects underwent colonoscopy with the investigator's combined instrument, and then underwent traditional colonoscopy with the same investigator

    Device: DeFrame

  • Experimental
    Trial Ⅱ

    Subjects underwent a traditional colonoscopy, followed by a colonoscopy with the same investigator's instrument

    Device: DeFrame

Interventions

  • DeviceDeFrame

    DeFrame can analyze colonoscopy medical images generated by electronic digestive endoscopy equipment to automatically identify, label and screen capture polyps in the colon.

06

What researchers measure

Primary outcomes

  1. PMR

    Polyp miss rate

    Time frame: during colonoscopy procedure

Secondary outcomes

  1. AMR

    Adenoma miss rate

    Time frame: during colonoscopy procedure

07

Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, 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 Sep 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05687318
Lead sponsor
Peking Union Medical College Hospital
Collaborators
The Second Hospital University of South China, Loudi Central Hospital
Responsible party
Sponsor
First posted
Jan 18, 2023
Start date
Sep 20, 2022
Primary completion
Apr 28, 2023
Completion
Aug 2, 2023
Last update
Sep 6, 2023

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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