NCT02534818

Brief Summary

The purpose of this study is to assess whether lower fluorescein sodium dosage can perceive the same detection rate per patient and per lesion for the detection of gastric intestinal metaplasia.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

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

June 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Last Updated

November 10, 2015

Status Verified

August 1, 2015

Enrollment Period

5 months

First QC Date

August 25, 2015

Last Update Submit

November 7, 2015

Conditions

Gastric Intestinal Metaplasia

Outcome Measures

Primary Outcomes (2)

  • Difference of the detection rate of gastric intestinal metaplasia between two fluosecein sodium dosage in a per-pateint analysis

    six months

  • Difference of the detection rate of gastric intestinal metaplasia between two dosage fluosecein sodium in a per-biopsy analysis

    six months

Study Arms (2)

Group 1

EXPERIMENTAL

lower fluorescein sodium dosage 0.02ml/kg for gastric intestinal metapalsia

Drug: lower fluorescein sodium dosage 0.02ml/kg

Group 2

ACTIVE COMPARATOR

conventional fluorescein sodium dosage 0.1ml/kg for gastric intestinal metapalsia

Drug: conventional fluorescein sodium dosage 0.1ml/kg

Interventions

lower fluorescein sodium dosage 0.02ml/kgDRUG

fluorescein Sodium Dose of 0.02ml/kg on gastric intestinal metapalsia

Group 1
conventional fluorescein sodium dosage 0.1ml/kgDRUG

fluorescein Sodium Dose of 0.1ml/kg on gastric intestinal metapalsia

Group 2

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with dyspeptic symptoms and aged 40 years or older
  • or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
  • or patients with family history of gastric cancer

You may not qualify if:

  • presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
  • presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
  • inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Study Officials

  • Yanqing Li, PhD. MD

    Department of Gastroenterology, Qilu Hospital, Shandong University

    STUDY DIRECTOR

Central Study Contacts

Yanqing Li, PhD. MD

CONTACT

18678827666qiluliyanqing@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Qilu Hospital

Study Record Dates

First Submitted

August 25, 2015

First Posted

August 28, 2015

Study Start

June 1, 2015

Primary Completion

November 1, 2015

Last Updated

November 10, 2015

Record last verified: 2015-08

Locations

CN(1)