NCT04765163

Brief Summary

Artificial intelligence is deeply integrated with medical diagnosis, and intelligent colonoscopy technology has broad room for development. At present, the assist device of colonoscopy is insufficiently studied. It is the part that needs to be further explored in the development of artificial intelligence colon diagnosis and treatment technology. The study will be conducted at the Digestive Endoscopy Center and it is expected that 380 subjects will participate voluntarily. Subjects met: 1) routine colonoscopy; 2) willing to provide relevant information required by the experiment; 3) signed informed consent for the study. This topic focuses on the colonoscope assist device, through the combination of power assisting device, dynamic analysis, and migration expert skills, to achieve a combination of intelligent power and precise treatment, and establish a prototype of the patient-colonoscopy-assisted assist system-doctor's four-in-one diagnosis and treatment system.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

2.5 years

First QC Date

January 26, 2021

Last Update Submit

February 19, 2021

Conditions

Keywords

Intelligence; Colonocope; Handle

Outcome Measures

Primary Outcomes (1)

  • Colonoscope operating handle model

    CPAS-I/II prototype system

    January 21, 2021

Secondary Outcomes (1)

  • Patents

    November 11, 2020

Study Arms (2)

physician group with assistive equipment

The number of colonoscopy operations completed per unit time and the degree of fatigue in the physician group using assistive equipment

Device: Intelligent Operating Handle

Physician group without assistive equipment

The number of colonoscopy operations completed per unit time and the degree of fatigue in the physician group without assistive equipment

Interventions

Intelligent Operating Handle

physician group with assistive equipment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

After full informed consent, outpatients undergoing a physical examination for colonoscopy

You may qualify if:

  • routine colonoscopy;
  • Willing to provide relevant information required by this experiment;
  • Sign the informed consent form for this study.

You may not qualify if:

  • can not tolerate colonoscopy;
  • Information about the requirements of this study cannot be provided;
  • Questionnaires cannot be conducted.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wang Ruigang

Beijing, China

Location

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 21, 2021

Study Start

May 11, 2019

Primary Completion

October 31, 2021

Study Completion

November 30, 2021

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations