Clinical trial · Interventional
Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)
NCT03228407CI-TRIAL-00031174unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Erosive Esophagitis | — | UNRESOLVED | — |
| Gastro Esophageal Reflux | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Confocal endomicroscopy | Procedure | — | UNRESOLVED |
| Endoscopic biopsies | Diagnostic Test | — | UNRESOLVED |
| Mucosal impedance (MI) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Non-erosive reflux disease (NERD)
- description
- Patient's with GERD refractory to PPI with no evidence of erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.
- interventionNames
- Procedure: Confocal endomicroscopy
- Diagnostic Test: Endoscopic biopsies
- Diagnostic Test: Mucosal impedance (MI)
- type
- ACTIVE_COMPARATOR
- label
- Barrett's esophagus/erosive esophagitis
- description
- Patient's with Barrett's esophagus or with erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.
- interventionNames
- Procedure: Confocal endomicroscopy
- Diagnostic Test: Endoscopic biopsies
- Diagnostic Test: Mucosal impedance (MI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \> 18 years 2. Ability to give informed consent Exclusion Criteria: 1. Pregnancy 2. Esophageal varices 3. Prior esophageal or gastric surgery 4. Active gastrointestinal bleeding 5. Evidence of esophageal malignancy 6. Inability to provide informed consent
References
Publications (4)
- BACKGROUNDVaezi MF, Choksi Y. Mucosal Impedance: A New Way To Diagnose Reflux Disease and How It Could Change Your Practice. Am J Gastroenterol. 2017 Jan;112(1):4-7. doi: 10.1038/ajg.2016.513. Epub 2016 Dec 13. No abstract available. PMID 27958288
- RESULTCui R, Zhou L, Lin S, Xue Y, Duan L, Xia Z, Jin Z, Zhang H, Zhang J, Song Z, Yan X. The feasibility of light microscopic measurements of intercellular spaces in squamous epithelium in the lower-esophagus of GERD patients. Dis Esophagus. 2011 Jan;24(1):1-5. doi: 10.1111/j.1442-2050.2010.01083.x. PMID 20626453
- RESULTTobey NA, Carson JL, Alkiek RA, Orlando RC. Dilated intercellular spaces: a morphological feature of acid reflux--damaged human esophageal epithelium. Gastroenterology. 1996 Nov;111(5):1200-5. doi: 10.1053/gast.1996.v111.pm8898633. PMID 8898633
- RESULTChu CL, Zhen YB, Lv GP, Li CQ, Li Z, Qi QQ, Gu XM, Yu T, Zhang TG, Zhou CJ, Rui-Ji, Li YQ. Microalterations of esophagus in patients with non-erosive reflux disease: in-vivo diagnosis by confocal laser endomicroscopy and its relationship with gastroesophageal reflux. Am J Gastroenterol. 2012 Jun;107(6):864-74. doi: 10.1038/ajg.2012.44. Epub 2012 Mar 13. PMID 22415199