Status:
UNKNOWN
Endoscopic Characterisation of Inflammation in EoE
Lead Sponsor:
University of Zurich
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
In this study, we plan to investigate the accuracy of the EG-760Z endoscope (135x zoom) compared with standard imaging with histology as gold standard in detecting and grading inflammatory activity in...
Detailed Description
Eosinophilic esophagitis (EoE) is a chronic-inflammatory disease of the esophagus. If left untreated, eosinophilic inflammation induces fibrosis, angiogenesis and stricture formation, finally resultin...
Eligibility Criteria
Inclusion
- Eligible are patients with histology-proven EoE in whom a follow-up endoscopy is indicated. Indications for follow-up endoscopy are i) determination of the response to PPI-Trial or ii) inadequate symptomatic relief despite established therapy.
- Type of treatment, or response to, have no implications on eligibility.
- Participants fulfilling all of the following inclusion criteria are eligible for the study:
- Patient is capable of giving informed consent
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Have histology proven EoE and are due to undergo follow-up gastroscopy or are due to undergo gastroscopy to investigate dyspepsia (control group)
- Male and Female patients 18 years to 80 years of age
Exclusion
- Contraindications to outpatient gastroscopy
- Contraindication for Non-anesthesia Provider Procedural Sedation and Analgesia: ASA class III or higher, morbid obesity (BMI \> 40 kg/m\^2), severe OSAS
- Contraindications to tissue sampling: oral anticoagulation in combination with antiaggregant such as aspirin or clopidogrel,
- Patients without subcutaneous veins that allow for insertion of peripheral venous catheters
- Women who are pregnant or breast feeding
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
- Participation in another study with investigational drug/device within the 30 days preceding and during the present study
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04769232
Start Date
March 1 2021
End Date
November 1 2021
Last Update
February 24 2021
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