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

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Contact Backup

Study Locations

  • China
    • 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:

  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.

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.

Sponsor

Renmin Hospital of Wuhan University

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.

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