Endoangel Withdrawal Overspeed Analysis

Colorectal Neoplasms Clinical Trial

Official title:

Explore the Relationship Between the Percentage of Overspeed of Colonoscopy Withdrawal and the Rate of Adenoma Detection:a Prospective、Multicenter、Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05069571
• Other study ID #: EA-21-009
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: September 2021
• Source: Renmin Hospital of Wuhan University
• Contact: Honggang Yu, Doctor
• Phone: 13871281899
• Email: yuhonggang[@]whu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Exploring the relationship between the percentage of overspeed of colonoscopy withdrawal and the rate of adenoma detection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1210
• Est. completion date: February 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males or females who are over 18 years old (inclusive);

2. Enteroscopy and related examinations are needed to further clarify the characteristics of digestive tract diseases;

3. Able to read, understand and sign the informed consent form;

4. The researcher believes that the subject can understand the process of the clinical research, is willing and able to complete all the research procedures and follow-up visits, and cooperate with the research procedures.

Exclusion Criteria:

1. Participated in other clinical trials, signed an informed consent form and within the follow-up period of other clinical trials;

2. Abuse of drugs or alcohol or mental disorders in the last 5 years;

3. Women during pregnancy or breastfeeding;

4. Subjects with previous history of bowel surgery;

5. The investigator believes that the subject is not suitable for enteroscopy and related examinations;

6. The investigator believes that the subject is not suitable for high-risk diseases or other special circumstances to participate in clinical trials.

7. Patients with gastrointestinal bleeding;

8. Known or highly suspected allergy to any ingredient of bowel cleansing agent;

9. Restricted activities or any mental or physical condition impairs their ability to drink intestinal cleansing preparations;

10. Known or suspected intestinal obstruction or perforation, toxic megacolon, most colectomy, heart failure (grade III or IV), severe cardiovascular disease, severe liver failure or end, renal insufficiency, etc.

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Other:
• Endoangel
Collecting the colonoscopy videos and analyzing the correlation between withdrawal overspeed proportion and adenoma detection rate.

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate		3 months
Secondary	Proportion of withdrawal overspeed		3 months