Ultrafine Endoscope for Colonoscopy in Diagnosis of Colorectal Diseases

NCT ID: NCT02160210

Last Updated: 2014-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colon Disease; Rectal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Ultrafine Endoscope

The ultrafine endoscope for colonoscopy with water method is performed in screening the colorectal diseases.

Group Type EXPERIMENTAL

Ultrafine Endoscope

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Transnasal gastroscope

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Youlin Yang ,MD

OTHER

Sponsor Role lead

Responsible Party

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Youlin Yang ,MD

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Youlin Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University

Locations

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The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

Countries

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China

Other Identifiers

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E-001

Identifier Type: -

Identifier Source: org_study_id

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