NCT02160210

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

June 10, 2014

Status Verified

June 1, 2014

Enrollment Period

2 months

First QC Date

June 9, 2014

Last Update Submit

June 9, 2014

Conditions

Colon Disease;Rectal Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Cecum intubation time

    up to two months

  • The time to reach the splenic flexure

    up to two months

  • The time to reach the hepatic flexure

    up to two months

  • The success rate of the cecal intubation within 15 minutes

    up to two months

Study Arms (1)

Ultrafine Endoscope

EXPERIMENTAL

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

Device: Ultrafine Endoscope

Interventions

Ultrafine EndoscopeDEVICE

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.

Also known as: Transnasal gastroscope
Ultrafine Endoscope

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnostic colonoscopy;
  • Subjects able to provide informed consent

You may not qualify if:

  • Patients with poor bowel preparation;
  • Contraindications of the colonoscopy;
  • Prior partial or complete colectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Harbin, Heilongjiang, 150001, China

Location

MeSH Terms

Conditions

Colonic DiseasesRectal Diseases

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Youlin Yang, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 9, 2014

First Posted

June 10, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

June 10, 2014

Record last verified: 2014-06

Locations

CN(1)