Research on Operating Handle of Colonoscope

• Conditions: Colonic Disease
• Interventions: Device: Intelligent Operating Handle

• Registration Number: NCT04765163
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-11
• Study First Submitted: 2021-01-26
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-19
• Last Update Submitted: 2021-02-19
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21
• Primary Completion: 2021-10-31
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
physician group with assistive equipment	Intelligent Operating Handle	The number of colonoscopy operations completed per unit time and the degree of fatigue in the physician group using assistive equipment

Primary Outcome Measures

Name	Time	Method
Colonoscope operating handle model	January 21, 2021	CPAS-I/II prototype system

Secondary Outcome Measures

Name	Time	Method
Patents	November 11, 2020	1. Patent number: 202010389077.8, A non-slip sleeve and a colonoscope handle; 2. Patent number: 202010388602.4, A colonoscopy operation auxiliary glove; 3. Patent number: 202011112968.5, A colonoscope control device

Trial Locations

Locations (1)

Wang Ruigang; 🇨🇳 Beijing, China