Ultrafine Endoscope for Colonoscopy in Diagnosis of Colorectal Diseases

June 9, 2014 updated by: Youlin Yang ,MD

Ultrafine Endoscope for Unsedated Colonoscopy is an Effective Method to Reduce Abdominal Pain:a Prospective Randomized Study.

This study is the evaluation of ultrafine endoscope (with small caliber and turning radius )for colonoscopy in decreasing abdominal pain of patients . 60 patients will be accepted in this trial.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to investigate the advantages of an endoscope with smaller turning radius and softer insert section in reducing patients' abdominal pain in colonoscopy. Transnasal gastroscope was selected in this study , because of its small caliber (5.9mm) and small turning radius . Visual analogue scale(VAS),cecum intubation time and cecum intubation rate were evaluated.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients diagnostic colonoscopy;
  2. Subjects able to provide informed consent

Exclusion Criteria:

  1. Patients with poor bowel preparation;
  2. Contraindications of the colonoscopy;
  3. Prior partial or complete colectomy

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrafine Endoscope
The ultrafine endoscope for colonoscopy with water method is performed in screening the colorectal diseases.
Device: Ultrafine Endoscope
Ultrafine endoscope reaching to the cecum within 15mins is thought to be successful.Water colonoscopy with standard colonoscope will be performed in unsuccessful subjects subsequently.
Other Names:
  • Transnasal gastroscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS abdominal pain scores
Time Frame: up to two months
VAS abdominal pain scores include pain scores in the insertion phase of splenic flexure,hepatic flexure,and ileocecal junction.(0=no pain and 10=most severe pain imaginable).
up to two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cecum intubation time
Time Frame: up to two months
Insertion time from rectum to reach the cecum.
up to two months
The time to reach the splenic flexure
Time Frame: up to two months
Insertion time from rectum to reach the flexure.
up to two months
The time to reach the hepatic flexure
Time Frame: up to two months
Insertion time from rectum to hepatic flexure.
up to two months
The success rate of the cecal intubation within 15 minutes
Time Frame: up to two months
Percentage of successful colonoscopy (insertion of ultrafine endoscope into cecum within 15 minutes).
up to two months

Collaborators and Investigators

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

Sponsor

Youlin Yang ,MD

Investigators

  • Principal Investigator: Youlin Yang, MD, Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical 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

June 1, 2014

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

June 9, 2014

First Submitted That Met QC Criteria

June 9, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Estimate)

June 10, 2014

Last Update Submitted That Met QC Criteria

June 9, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-001

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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