Evaluating Sedation-Free Transnasal Endoscopy to Improve Access and Reduce Costs for Upper Gastrointestinal Evaluations in Adults with Bariatric Conditions

What this Trial Is About

Researchers are studying the use of the EvoEndo Endoscopy system, an ultra-slim, single-use endoscope designed for transnasal endoscopy, to evaluate and provide care for upper gastrointestinal tract diseases in adults undergoing bariatric treatment. This study aims to improve safety, reduce costs, and increase access to endoscopic care compared to traditional methods, particularly for those with obesity and related gastrointestinal conditions. The study focuses on the potential benefits of sedation-free transnasal endoscopy in the bariatric population, addressing challenges of current sedated oral endoscopy methods that can delay diagnosis and increase morbidity and costs. The trial compares two methods sedation-free transnasal endoscopy through the nose using the EvoEndo system and standard sedated esophagogastroduodenoscopy EGD through the mouth. Participants receive either an unsedated endoscopic evaluation via the transnasal endoscope or a sedated endoscopic evaluation with a standard upper endoscope. These procedures are conducted in an ambulatory bariatric clinic setting to assess the impact on diagnosis speed, intervention timing, patient and clinic costs, and provider experience. Participants undergo endoscopic assessments and are monitored for outcomes such as patient interest, satisfaction, procedure duration, time to diagnosis, biopsy sample adequacy, cost comparison, and adverse events. Surveys are completed up to seven days after the procedure, with follow-up evaluations extending up to 30 days. The study collects detailed data to evaluate the safety and effectiveness of the transnasal endoscopy system while tracking patient and clinic experiences during the trial period, which lasts until mid-2028.

Trans-nasal Endoscopy for Bariatric Patients