What this study is
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.
What's being tested
- Transnasal Endoscopy
Intervention · DEVICE
Unsedated endoscopic evaluation through the nose.
- Esophagogastroduodenoscopy
Intervention · PROCEDURE
Sedated endoscopic evaluation through the mouth.
Study details
- Official title
- Use of Sedation-Free Transnasal Endoscopy to Improve Access and Lower Costs of Endoscopic Evaluations in a Bariatric Medical and Surgical Program
- Sponsor
- Christopher C. Thompson, MD, MSc
- Conditions
- Obesity · Obesity, Morbid · Obese · GI Disorders · Gastrointestinal Diseases
- Enrolling
- 100 people
- Starts
- 2025-12
- Est. completion
- 2027-06
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 90 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Patient <18 years of age
- Medically contraindicated to perform EGD or TNE
- Inability to provide informed consent
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBrigham and Women's Hospital
Boston, Massachusetts, United States
- Michele B. Ryan, MS · Contact6175258266mryan@bwh.harvard.edu
- Christopher C. Thompson, MD, MSc · Principal investigator
Recruiting
Study team
Sponsor
Christopher C. Thompson, MD, MSc
Study ID 2023P002683
Principal investigator
Christopher C. Thompson, MD, MSc
Brigham and Womens Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.