Trans-nasal Endoscopy for Bariatric Patients
NCT06200961 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-03-02
Summary
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.
Conditions
Interventions
- DEVICE
-
Transnasal Endoscopy
Unsedated endoscopic evaluation through the nose.
- PROCEDURE
-
Esophagogastroduodenoscopy
Sedated endoscopic evaluation through the mouth.
Sponsors & Collaborators
-
EvoEndo, Inc.
collaborator UNKNOWN -
Christopher C. Thompson, MD, MSc
lead OTHER
Principal Investigators
-
Christopher C. Thompson, MD, MSc · Brigham and Womens Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2027-06-30
- Completion
- 2027-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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