NCT02632682

Brief Summary

Real-time Diagnosis of Barrett's Esophagus: Comparing Confocal Laser Endomicroscopy with Conventional Histology for the Identification of Specialized Intestinal Metaplasia

Trial Health

100
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

December 4, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 2, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

December 4, 2015

Last Update Submit

November 30, 2016

Conditions

Barrett's Esophagus

Keywords

probe-based confocal laser endomicroscopy

Outcome Measures

Primary Outcomes (1)

  • Probe-based confocal laser endomicroscopy (pCLE) will be compared to standard histologic analysis in the evaluation of Barrett's esophagus.

    Metrics for the study will include "positive" or "negative" for Barrett's esophagus.

    8 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Age \>18 * Clinical diagnosis of GERD * Undergoing upper endoscopy for reflux evaluation

You may qualify if:

  • Age \>18; Clinical diagnosis of GERD; Undergoing upper endoscopy for reflux evaluation

You may not qualify if:

  • Age \<18, Contraindication to receiving fluorescein, Inability to provide informed consent, History of esophageal ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2015

First Posted

December 17, 2015

Study Start

February 1, 2016

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

December 2, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share