Use of Sedation-Free Transnasal Endoscopy to Improve Access and Lower Costs of Endoscopic Evaluations in a Bariatric Medical and Surgical Program

What this Trial Is About

This research aims to evaluate if the EvoEndo Endoscopy system can be used to assess and provide care for upper gastrointestinal tract diseases in adults who are part of a bariatric program. It focuses on a newly FDA-cleared ultra-slim, single-use endoscope designed for transnasal endoscopy, which might improve safety, reduce costs, and enhance access to endoscopic care compared to larger scopes currently used. The study addresses challenges with traditional sedated oral endoscopy, especially in high-risk bariatric patients. Participants will undergo either unsedated transnasal endoscopy using the ultra-slim device through the nose or sedated esophagogastroduodenoscopy EGD using a standard scope through the mouth. The study compares these two methods in an ambulatory bariatric clinic setting to evaluate their impact on diagnosis timing, patient and clinic costs, and provider experience. The transnasal endoscopy procedure is sedation-free, potentially offering a safer and more accessible alternative. During the study, participants will be assessed with surveys about their experience and satisfaction within 7 days after the procedure. Researchers will also measure procedure duration, time to diagnosis, biopsy sample quality, costs, and any adverse events up to 30 days post-procedure. This comprehensive evaluation aims to understand how introducing sedation-free transnasal endoscopy affects patient care and clinic operations over the trial period, which runs until December 2027.

Trans-nasal Endoscopy for Bariatric Patients