Recruiting

Trans-nasal Endoscopy

Sponsor:

Christopher C. Thompson, MD, MSc

Code:

NCT06200961

Conditions

Obesity

Obesity, Morbid

Obese

GI Disorders

Gastrointestinal Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transnasal Endoscopy

Esophagogastroduodenoscopy

Study Details

Brief 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

Obesity

Obesity, Morbid

Obese

GI Disorders

Gastrointestinal Diseases

Study ID

NCT06200961

Start date

Apr 20, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Transnasal Endoscopy

Unsedated endoscopic evaluation through the nose.

Esophagogastroduodenoscopy

Sedated endoscopic evaluation through the mouth.

Primary outcome measure

  • Experience survey [ Time Frame: Up to 7 days post procedure ]

Central Contacts and Locations

Central contacts

Michele B Ryan, MS

617-525-8266mryan@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Michele B. Ryan, MS

6175258266mryan@bwh.harvard.edu

Principal Investigator:

Christopher C. Thompson, MD, MSc

More Information

Sponsor

Christopher C. Thompson, MD, MSc

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • Transnasal Endoscopy (TNE)
  • Esophagogastroduodenoscopy (EGD)
  • Upper Endoscopy
  • Endoscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christopher C. Thompson, MD, MSc on 2026-06-25.