- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05069571
Endoangel Withdrawal Overspeed Analysis
September 24, 2021 updated by: Renmin Hospital of Wuhan University
Explore the Relationship Between the Percentage of Overspeed of Colonoscopy Withdrawal and the Rate of Adenoma Detection:a Prospective、Multicenter、Observational Study
Exploring the relationship between the percentage of overspeed of colonoscopy withdrawal and the rate of adenoma detection.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
1210
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Honggang Yu, Doctor
- Phone Number: 13871281899
- Email: yuhonggang@whu.edu.cn
Study Contact Backup
- Name: Liwen Yao, Doctor
- Phone Number: 15827416837
- Email: 292779656@qq.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430060
- Recruiting
- Renmin Hospital of Wuhan University
-
Contact:
- Honggang Yu, Doctor
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients need to receive the colonoscopy examination.
Description
Inclusion Criteria:
- Males or females who are over 18 years old (inclusive);
- Enteroscopy and related examinations are needed to further clarify the characteristics of digestive tract diseases;
- Able to read, understand and sign the informed consent form;
- 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:
- Participated in other clinical trials, signed an informed consent form and within the follow-up period of other clinical trials;
- Abuse of drugs or alcohol or mental disorders in the last 5 years;
- Women during pregnancy or breastfeeding;
- Subjects with previous history of bowel surgery;
- The investigator believes that the subject is not suitable for enteroscopy and related examinations;
- The investigator believes that the subject is not suitable for high-risk diseases or other special circumstances to participate in clinical trials.
- Patients with gastrointestinal bleeding;
- Known or highly suspected allergy to any ingredient of bowel cleansing agent;
- Restricted activities or any mental or physical condition impairs their ability to drink intestinal cleansing preparations;
- 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.
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-Crossover
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adenoma detection rate
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proportion of withdrawal overspeed
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
March 1, 2020
Primary Completion (Anticipated)
November 1, 2021
Study Completion (Anticipated)
February 1, 2022
Study Registration Dates
First Submitted
September 24, 2021
First Submitted That Met QC Criteria
September 24, 2021
First Posted (Actual)
October 6, 2021
Study Record Updates
Last Update Posted (Actual)
October 6, 2021
Last Update Submitted That Met QC Criteria
September 24, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA-21-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.