N/A
Completed N=164
CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
Barrett Syndrome · Barrett's Syndrome · Barrett's esophagus · Barrett Esophagus
Source: ClinicalTrials.gov NCT01032044 ↗
Enrolled (actual)
164
Serious AEs
0.6%
Results posted
Apr 2016
Primary outcomePrimary: Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated" — 16; 16 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated" |
16; 16 | — |
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
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. Informational only — not medical advice.