Research on Operating Handle of Colonoscope

Colonic Disease Clinical Trial

— ROHC  

Official title:

Research on Intelligent Assist System of Colonoscope Operating Handle

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04765163
• Other study ID #: XXT17
• Status: Enrolling by invitation
• Start date: May 11, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: February 2021
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2
• Est. completion date: November 30, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Disease
• Colonic Diseases

Intervention

Device:
• Intelligent Operating Handle
Intelligent Operating Handle

Locations

Country	Name	City	State
China	Wang Ruigang	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colonoscope operating handle model	CPAS-I/II prototype system	January 21, 2021
Secondary	Patents	Patent number: 202010389077.8, A non-slip sleeve and a colonoscope handle; Patent number: 202010388602.4, A colonoscopy operation auxiliary glove; Patent number: 202011112968.5, A colonoscope control device	November 11, 2020