Trans-nasal Endoscopy for Bariatric Patients

NCT06200961 | Recruiting FDA Device

• 1 other identifier: 2023P002683
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Experience survey

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

  Up to 7 days post procedure

Secondary Outcomes (9)

• Patient interest

  Baseline

• Patient satisfaction - mGHAA-9

  Up to 7 days post procedure

• Patient satisfaction - TNE Post-procedure evaluation

  Up to 7 days post procedure

• Duration of procedure

  Up to 7 days post procedure

• Total Endoscopy Experience duration

  Up to 7 days post procedure

Study Arms (2)

Transnasal Endoscopy (TNE)

ACTIVE COMPARATOR

Unsedated endoscopic evaluation of the esophagus and stomach through the nose with a transnasal endoscope.

Device: Transnasal Endoscopy

Sedated Esophagogastroduodenoscopy (EGD)

ACTIVE COMPARATOR

Sedated endoscopic evaluation of the esophagus and stomach through the mouth with a standard upper endoscope.

Procedure: Esophagogastroduodenoscopy

Interventions

Transnasal Endoscopy DEVICE

Unsedated endoscopic evaluation through the nose.

Also known as: TNE

Transnasal Endoscopy (TNE)

Esophagogastroduodenoscopy PROCEDURE

Sedated endoscopic evaluation through the mouth.

Also known as: EGD

Sedated Esophagogastroduodenoscopy (EGD)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify if:

• Patient \<18 years of age
• Medically contraindicated to perform EGD or TNE
• Inability to provide informed consent

Sponsors & Collaborators

• Christopher C. Thompson, MD, MSc: lead
• EvoEndo, Inc.: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Obesity; Obesity, Morbid; Digestive System Diseases; Gastrointestinal Diseases

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Christopher C. Thompson, MD, MSc

  Brigham and Womens Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele B Ryan, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Endoscopy

Model Details: Case Control

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 11, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)