NCT02158260

Brief Summary

It is a single center, prospective and self-controlled trial. We'd like to explore a new method by changing position to reduce gastric missing areas in Capsule Endoscopy(CE)

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

June 6, 2014

Status Verified

June 1, 2014

Enrollment Period

1.7 years

First QC Date

May 31, 2014

Last Update Submit

June 5, 2014

Conditions

Capsule Endoscopy

Keywords

Capsule endoscopyPatient position changing

Outcome Measures

Primary Outcomes (1)

  • visualization of gastric mucosa

    Gastric preparation included the degree of cleanliness and distention.Cleanliness was evaluated by 3 grades: good (the fluid was transparent and \<5% of gastric mucosa was obscured by stomach contents), moderate (the fluid was a little opaque or 5% to 10% of gastric mucosa was obscured by stomach contents) and poor (the fluid was opaque or \>10% of gastric mucosa was obscured by stomach contents). Distention was evaluated by 3 grades: good (existence of a small amount of gastric folds), moderate (existence of significant amount of gastric folds and gastric cavity was smaller than expected) and poor (gastric cavity was not inflated).

    1 year

Secondary Outcomes (1)

  • rate of lesion detection

    1 year

Study Arms (2)

position changing

EXPERIMENTAL

During the examination, subjects changed position in the following sequence: left lateral head-down position, supine position, prone head-down position, right lateral head-down position, supine position, left lateral position, prone position, prone hip-high position, right lateral position and sitting position.

Behavioral: Position changing

free position

NO INTERVENTION

Interventions

Position changingBEHAVIORAL
position changing

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects don't have swallowing difficulties, motility disorders, or a medical history that included abdominal surgery or obvious gastrointestinal strictures are included.

You may not qualify if:

  • Subjects with swallowing difficulty, motility disorders, diabetes, life-threatening conditions, mental disorders, or patients that could be pregnant, have a cardiac pacemaker, electrical implant, or any other condition that would preclude compliance with the study requirements and/or device instructions are excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

Study Officials

  • Side Liu, phD

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zelong Han, MD

CONTACT

15360093622hzl198886@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor,MD,phD

Study Record Dates

First Submitted

May 31, 2014

First Posted

June 6, 2014

Study Start

September 1, 2013

Primary Completion

June 1, 2015

Last Updated

June 6, 2014

Record last verified: 2014-06

Locations

CN(1)