Clinical trial · Interventional
CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Barrett Esophagus | — | UNRESOLVED | — |
| Barrett's Esophagus | — | UNRESOLVED | — |
| Barrett's Syndrome | — | UNRESOLVED | — |
| Barrett Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pCLE guided evaluation | Device | — | UNRESOLVED |
| Standard endoscopic evaluation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard endoscopic evaluation
- description
- Standard high-definition white light endoscopy guided evaluation
- interventionNames
- Device: Standard endoscopic evaluation
- type
- EXPERIMENTAL
- label
- pCLE-guided evaluation
- description
- Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)
- interventionNames
- Device: pCLE guided evaluation
Primary outcomes (1)
- measure
- Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated"
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWallace MB, Crook JE, Saunders M, Lovat L, Coron E, Waxman I, Sharma P, Hwang JH, Banks M, DePreville M, Galmiche JP, Konda V, Diehl NN, Wolfsen HC. Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus. Gastrointest Endosc. 2012 Sep;76(3):539-47.e1. doi: 10.1016/j.gie.2012.05.004. Epub 2012 Jun 28. PMID 22749368