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Imaging of the Esophagus Using a SECM Capsule
The goal of this validation study is to compare Spectrally Encoded Confocal Microscopy (SECM) Tethered Capsule Endoscopy (TCE) diagnosis of Eosinophilic Esophagitis to that of standard of care endoscopic biopsy.
Conditions:
🦠 Eosinophilic Esophagitis 🦠 Barrett Esophagus
🗓️ Study Start (Actual) 1 January 2025
🗓️ Primary Completion (Estimated) 30 December 2026
✅ Study Completion (Estimated) 30 December 2027
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 12 years of age or older undergoing endoscopic biopsy for evaluation of EoE
    • * Able to give informed consent

    Exclusion Criteria:

    • * Inability to swallow pills and capsules
    • * Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule
Ages Eligible for Study: 12 Years to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 23 May 2018
  • First Submitted that Met QC Criteria 23 May 2018
  • First Posted 6 June 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 May 2024
  • Last Update Posted 13 May 2024
  • Last Verified May 2024
I'm interested ...!!