CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 164 enrolled
Drug / intervention
Standard endoscopic evaluation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01032044
NCT01032044N/ACompleted

Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia

Mauna Kea Technologies·interventional·Posted Dec 15, 2009·Updated Apr 22, 2016

In Brief

A clinical study evaluating Standard endoscopic evaluation and pCLE guided evaluation for Barrett Syndrome and 4 related conditions. Completed, enrolled 164 participants across 6 sites in 3 countries.

Detailed Summary

This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE). It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, United Kingdom, United States
CollaboratorsCellvizio Inc.

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 15, 2009
Enrollment StartFeb 1, 2010
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.5 years ago

Interventions

Standard endoscopic evaluationdevice

Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy

pCLE guided evaluationdevice

Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure.