Clinical trial

Trans-nasal Endoscopy for Bariatric Patients

Recruiting now · Not applicable · 1 countries · Registry ID NCT06200961

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 90 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Obesity, Morbid, Obese, GI Disorders, Gastrointestinal Diseases

Full registry criteria

Inclusion Criteria: 1. Patient 18 years of age and less than 90 years of age with clinically referred for esophagoscopy, gastroscopy, or esophagogastroduodenoscopy (EGD) 2. Cared for in metabolic and bariatric clinic Exclusion Criteria: 1. Patient \<18 years of age 2. Medically contraindicated to perform EGD or TNE 3. Inability to provide informed consent

Treatments and study arms

Transnasal Endoscopy

Device

Unsedated endoscopic evaluation through the nose.

Esophagogastroduodenoscopy

Procedure

Sedated endoscopic evaluation through the mouth.

Primary outcomes

Experience surveyUp to 7 days post procedure

Evaluate the experience of patients and provider teams utilizing sedation-free transnasal endoscopy for evaluation of upper gastrointestinal (GI) conditions

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Brigham and Women's Hospital🇺🇸 Boston, Massachusetts, United States

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Michele B. Ryan, MSContact

Email · Call 6175258266

Christopher C. Thompson, MD, MScPrincipal Investigator