Ultrafine Endoscope for Colonoscopy in Diagnosis of Colorectal Diseases

Rectal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02160210
• Other study ID #: E-001
• Status: Not yet recruiting
• Phase: N/A
• First received: June 9, 2014
• Last updated: June 9, 2014
• Start date: June 2014
• Est. completion date: August 2014

Study information

• Verified date: June 2014
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colon Disease;
• Colonic Diseases
• Rectal Disease
• Rectal Diseases

Intervention

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.

Locations

Country	Name	City	State
China	The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Youlin Yang ,MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS abdominal pain scores	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	No
Secondary	Cecum intubation time	Insertion time from rectum to reach the cecum.	up to two months	No
Secondary	The time to reach the splenic flexure	Insertion time from rectum to reach the flexure.	up to two months	No
Secondary	The time to reach the hepatic flexure	Insertion time from rectum to hepatic flexure.	up to two months	No
Secondary	The success rate of the cecal intubation within 15 minutes	Percentage of successful colonoscopy (insertion of ultrafine endoscope into cecum within 15 minutes).	up to two months	No