Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Barrett Syndrome
- Sponsor
- Mauna Kea Technologies
- Enrollment
- 164
- Locations
- 6
- Primary Endpoint
- Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated"
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Detailed Description
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 guided evaluation (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.
Investigators
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
- •\<2cm of circumferential BE and \<5 total islands of BE on prior to last ablation.
- •Age \> 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
Outcomes
Primary Outcomes
Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated"
Time Frame: 3 month follow-up endoscopic procedure
Number of Barrett's Esophagus (BE) Participants with a Composite Outcome of "Optimally Treated", in each group defined as patients for whom all lesions are ablated when disease is present, or not ablated when disease is absent, or have complete ablation of all disease at the 3 month follow-up.