N/A N=164 Randomized Single-blind Diagnostic

CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia

Barrett Syndrome · Barrett's Syndrome · Barrett's Esophagus · Barrett Esophagus · Adenocarcinoma

Bottom Line

View on ClinicalTrials.gov: NCT01032044 ↗

Enrolled (actual)

164

Serious AEs

0.6%

Results posted

Apr 2016

Primary outcome: Primary: Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated" — 16; 16 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Standard endoscopic evaluation (Device); pCLE guided evaluation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mauna Kea Technologies
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated"	16; 16	—

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.

Eligibility Criteria

Inclusion Criteria

Patients with BE with Intestinal Metaplasia, Low Grade-IntraEpithelial Neoplasia/High Grade-IntraEpithelial Neoplasia as the original indication for ablative treatment.
Undergoing any type of endoscopic BE ablation treatment
18 years
Ability to provide written, informed consent

Exclusion Criteria

Participation in another clinical study
Circumferential BE
Complete eradication of BE documented by biopsies
Inability to obtain biopsies due to anticoagulation, varices, etc.
Allergy to fluorescein
Pregnancy
Renal insufficiency

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01032044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.