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ObesityDiagnostics and screeningDeviceProcedure

What this study is

This study plans to learn if the EvoEndo Endoscopy system can be used to evaluate, provide and follow up care for upper gastrointestinal tract diseases in the bariatric population. The smallest current scope available for such a technique is an adult transnasal endoscope with a larger diameter, a pulmonary bronchoscope or Ear Nose and Throat (ENT) laryngoscope. This study is evaluating a newly Food and Drug Administration (FDA) cleared ultra-slim, single-use, endoscope specifically designed for transnasal endoscopy to evaluate its use in adult upper tract gastrointestinal diseases. If such a technique is successful it could improve the safety, cost, and access of endoscopic care for patients in need of an endoscopic evaluation for a bariatric medical condition.

What's being tested

  • Transnasal Endoscopy

    Intervention · DEVICE

    Unsedated endoscopic evaluation through the nose.

  • Esophagogastroduodenoscopy

    Intervention · PROCEDURE

    Sedated endoscopic evaluation through the mouth.

Study details

Official title
Use of Sedation-Free Transnasal Endoscopy to Improve Access and Lower Costs of Endoscopic Evaluations in a Bariatric Medical and Surgical Program
Sponsor
Christopher C. Thompson, MD, MSc
Conditions
Obesity · Obesity, Morbid · Obese · GI Disorders · Gastrointestinal Diseases
Enrolling
100 people
Starts
2025-12
Est. completion
2027-06
Design
Open-label, non-randomized, parallel groups
Record
View on ClinicalTrials.gov ↗