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Ultrafine Endoscope for Colonoscopy in Diagnosis of Colorectal Diseases

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ClinicalTrials.gov Identifier: NCT02160210
Recruitment Status : Unknown
Verified June 2014 by Youlin Yang ,MD, First Affiliated Hospital of Harbin Medical University.
Recruitment status was:  Not yet recruiting
First Posted : June 10, 2014
Last Update Posted : June 10, 2014
Sponsor:
Information provided by (Responsible Party):
Youlin Yang ,MD, First Affiliated Hospital of Harbin Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colon Disease; Rectal Disease Device: Ultrafine Endoscope Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Ultrafine Endoscope for Unsedated Colonoscopy is an Effective Method to Reduce Abdominal Pain:a Prospective Randomized Study.
Study Start Date : June 2014
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


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 Name: Transnasal gastroscope




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Cecum intubation time [ Time Frame: up to two months ]
    Insertion time from rectum to reach the cecum.

  2. The time to reach the splenic flexure [ Time Frame: up to two months ]
    Insertion time from rectum to reach the flexure.

  3. The time to reach the hepatic flexure [ Time Frame: up to two months ]
    Insertion time from rectum to hepatic flexure.

  4. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160210


Locations
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China, Heilongjiang
The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
Sponsors and Collaborators
Youlin Yang ,MD
Investigators
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Principal Investigator: Youlin Yang, MD Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University
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Responsible Party: Youlin Yang ,MD, Professor, First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT02160210    
Other Study ID Numbers: E-001
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Rectal Diseases
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases