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

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Michele B Ryan, MS
mryan@bwh.harvard.edu
617-525-8266
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2027-12
Participants
Target number of participants: 100
Treatments
Active_comparator: Transnasal Endoscopy (TNE)
Unsedated endoscopic evaluation of the esophagus and stomach through the nose with a transnasal endoscope.
Active_comparator: Sedated Esophagogastroduodenoscopy (EGD)
Sedated endoscopic evaluation of the esophagus and stomach through the mouth with a standard upper endoscope.
Related Therapeutic Areas
Sponsors
Collaborators: EvoEndo, Inc.
Leads: Christopher C. Thompson, MD, MSc

This content was sourced from clinicaltrials.gov