Trans-nasal Endoscopy for Bariatric Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorChristopher C. Thompson, MD, MSc

About this trial

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.

Eligibility criteria

Qualifiers

Patient 18 years of age and less than 90 years of age with clinically referred for esophagoscopy, gastroscopy, or esophagogastroduodenoscopy (EGD)

Cared for in metabolic and bariatric clinic

Disqualifiers

Patient <18 years of age

Medically contraindicated to perform EGD or TNE

Inability to provide informed consent

Trial design

Treatments tested in this trial

  • Transnasal Endoscopy
  • Esophagogastroduodenoscopy

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Christopher C. Thompson, MD, MSc

Lead sponsor

Brigham and Women's Hospital

Sponsor institution

EvoEndo, Inc.

Collaborator