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

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, a Prospective, Multicenter, Randomized Stratified Block, Incomplete Blind Setting, Parallel Sequential Control, and Efficacy Test

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05687318

Enrollment

337

Registered

2023-01-18

Start date

2022-09-20

Completion date

2023-08-02

Last updated

2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Intelligence, Enteroscope, Intestinal Polyposis, Adenomatous

Brief 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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

* (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.

Design outcomes

Primary

Measure	Time frame	Description
PMR	during colonoscopy procedure	Polyp miss rate

Secondary

Measure	Time frame	Description
AMR	during colonoscopy procedure	Adenoma miss rate

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026