ROHC: Research on Operating Handle of Colonoscope

• Sponsor: Beijing Tsinghua Chang Gung Hospital (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04765163
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Anticipated Duration (Months): 30.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Disease	Device: Intelligent Operating Handle

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 2 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Research on Intelligent Assist System of Colonoscope Operating Handle
• Actual Study Start Date: May 11, 2019
• Anticipated Primary Completion Date: Oct 31, 2021
• Anticipated Study Completion Date: Nov 30, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Colonoscope operating handle model [January 21, 2021]

   CPAS-I/II prototype system

Secondary Outcome Measures

1. Patents [November 11, 2020]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wang Ruigang	Beijing		China

Sponsors and Collaborators

• Beijing Tsinghua Chang Gung Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beijing Tsinghua Chang Gung Hospital
• ClinicalTrials.gov Identifier: NCT04765163
• Other Study ID Numbers: XXT17
• First Posted: Feb 21, 2021
• Last Update Posted: Feb 21, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Beijing Tsinghua Chang Gung Hospital: Intelligence; Colonocope; Handle
• Additional relevant MeSH terms: Colonic Diseases

Study Results

No Results Posted as of Feb 21, 2021