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
|Condition or disease||Intervention/treatment||Phase|
|Colon Disease; Rectal Disease||Device: Ultrafine Endoscope||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|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|
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
- 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).
- Cecum intubation time [ Time Frame: up to two months ]Insertion time from rectum to reach the cecum.
- The time to reach the splenic flexure [ Time Frame: up to two months ]Insertion time from rectum to reach the flexure.
- The time to reach the hepatic flexure [ Time Frame: up to two months ]Insertion time from rectum to hepatic flexure.
- 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).
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
|The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University|
|Harbin, Heilongjiang, China, 150001|
|Principal Investigator:||Youlin Yang, MD||Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University|