NCT02336100

Brief Summary

Gastroesophageal reflux disease (GERD) patients without obvious mucosal break by endoscopy were examined by FICE, followed by confocal. Validity scores for MERD diagnosis were analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

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, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 12, 2015

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

January 6, 2015

Last Update Submit

February 26, 2019

Conditions

Gastroesophageal Reflux Disease

Keywords

Diagnostic technique and procedure

Outcome Measures

Primary Outcomes (2)

  • MERD diagnosis from FICE plus pCLE.

    8 months

  • Interobserver agreement in pCLE for MERD diagnosis

    8 months

Study Arms (2)

GERD patient

EXPERIMENTAL

36 GERD patients without obviously abnormality were examined by FICE and then followed by pCLE to evaluate minimal change esophagitis

Device: Endoscopy (FICE and pCLE)

Control

EXPERIMENTAL

18 control patients were were examined by FICE and then followed by pCLE to evaluate minimal change esophagitis

Device: Endoscopy (FICE and pCLE)

Interventions

Endoscopy (FICE and pCLE)DEVICE

FICE is Flexible Spectral Imaging Color Enhancement and pCLE is probe-based Confocal Lase Endomicroscopy

ControlGERD patient

Eligibility Criteria

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

You may qualify if:

  • age more than 18 year old
  • no PPI therapy in previous 2 weeks and
  • no esophageal tumor or stenosis or history of esophageal surgery.

You may not qualify if:

  • bleeding tendency including decompensated cirrhosis, chronic kidney disease
  • long term antiplatelets or anticoagulants,
  • pregnancy or
  • history of fluorescein allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, Patum Wan, 10330, Thailand

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Rapat Pittayanon, MD

    king

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastrointestinal Unit, King Chulalongkorn Memorial Hospital

Study Record Dates

First Submitted

January 6, 2015

First Posted

January 12, 2015

Study Start

June 1, 2011

Primary Completion

February 1, 2012

Study Completion

June 1, 2012

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

TH(1)