Back to results

Quantitative Bowel Readiness Assessment System in Predicting the Missed Detection Rate of Adenomas

Primary Purpose

Self Control, Prospective, Interventional

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Bowel readiness

About this trial

This is an interventional diagnostic trial for Self Control

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

At least 4 operators were included in this study, and the operating years of colonoscopy were ≥ 5 years, and the number of independent operating cases was ≥ 3000.

Subjects who meet all of the following specific criteria will be considered for participation in the study:

Male or female with age ≥ 45 years inclusive;
Able to read, understand and sign informed consent;
The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures.

Exclusion Criteria:

Subjects who meet any of the following specific criteria will be refused to participate in the study:

have a history of drug or alcohol abuse or psychological disorders within the last 5 years;
Pregnant or lactating women;
Patients with known multiple polyp syndrome;
patients with known inflammatory bowel disease;
known intestinal stenosis or space-occupying tumor;
known colon obstruction or perforation;
patients with a history of colorectal surgery;
Patients with previous history of allergy to pre-used spasmolysis;
Unable to perform biopsy and polyp removal due to coagulation disorders or oral anticoagulants;
High risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.

Sites / Locations

Renmin Hospital of Wuhan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bowel readiness

Arm Description

Outcomes

Primary Outcome Measures

Missed detection rate of ≥5mm adenoma

(≥ 5mm adenoma missed rate, ≥ 5mm AMR) : Each patient will receive two colonoscopy examinations. The ≥ 5mm adenoma that were not detected in the first colonoscopy was define as missed ≥ 5mm adenoma. Numerator is the number of missed detection of ≥5mm adenomas during colonoscopy, and denominator is the total number of ≥ 5mm adenomas receiving colonoscopy.

Secondary Outcome Measures

Full Information

NCT ID

NCT05145712

First Posted

July 20, 2021

Last Updated

November 22, 2021

Sponsor

Renmin Hospital of Wuhan University

1. Study Identification

Unique Protocol Identification Number

NCT05145712

Brief Title

Quantitative Bowel Readiness Assessment System in Predicting the Missed Detection Rate of Adenomas

Official Title

A Single-center Study of an AI-assisted Quantitative Bowel Readiness Assessment System in Predicting the Missed Detection Rate of Adenomas Under Colonoscopy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

July 21, 2021 (Actual)

Primary Completion Date

January 30, 2022 (Anticipated)

Study Completion Date

March 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Renmin Hospital of Wuhan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

To verify the correlation between the proposed artificial intelligence based bowel preparation assessment system and the missed detection rate of adenomas, and to evaluate whether the system can effectively assist doctors in identifying patients who need to be re-examined by colonoscopy due to poor intestinal cleanliness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Self Control, Prospective, Interventional

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

263 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bowel readiness

Arm Type

Experimental

Intervention Type

Diagnostic Test

Intervention Name(s)

Bowel readiness

Intervention Description

During the examination, the endoscopic physician required to stay in place while rinsing, and the lens could only be withdrawn after rinsing. During the examination, the recorder should record the time points of the right colon, transverse colon, and left colon, as well as the time of irrigation. If both are considered to be properly, then second colonoscopy was performed immediately. If both results agree or either side agrees that the gut is not well prepared, the review will be carried out within a year

Primary Outcome Measure Information:

Title

Missed detection rate of ≥5mm adenoma

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At least 4 operators were included in this study, and the operating years of colonoscopy were ≥ 5 years, and the number of independent operating cases was ≥ 3000. Subjects who meet all of the following specific criteria will be considered for participation in the study: Male or female with age ≥ 45 years inclusive; Able to read, understand and sign informed consent; The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures. Exclusion Criteria: Subjects who meet any of the following specific criteria will be refused to participate in the study: have a history of drug or alcohol abuse or psychological disorders within the last 5 years; Pregnant or lactating women; Patients with known multiple polyp syndrome; patients with known inflammatory bowel disease; known intestinal stenosis or space-occupying tumor; known colon obstruction or perforation; patients with a history of colorectal surgery; Patients with previous history of allergy to pre-used spasmolysis; Unable to perform biopsy and polyp removal due to coagulation disorders or oral anticoagulants; High risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Honggang Yu, PhD

Phone

13871281899

yuhonggang1969@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Honggang Yu, PhD

Organizational Affiliation

Renmin Hospital of Wuhan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Renmin Hospital of Wuhan University

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

027

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Boru Chen, master

Phone

15071054942

2201017920@qq.com

12. IPD Sharing Statement

Learn more about this trial

Quantitative Bowel Readiness Assessment System in Predicting the Missed Detection Rate of Adenomas

We'll reach out to this number within 24 hrs