Research on Operating Handle of Colonoscope (ROHC)

February 19, 2021 updated by: Beijing Tsinghua Chang Gung Hospital

Research on Intelligent Assist System of Colonoscope Operating Handle

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Wang Ruigang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colonoscope operating handle model
Time Frame: January 21, 2021
CPAS-I/II prototype system
January 21, 2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patents
Time Frame: 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
November 11, 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tsinghua Chang Gung Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2019

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

February 19, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 19, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XXT17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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