Trans-nasal Endoscopy for Bariatric Patients (TNE)

June 23, 2026 updated by: Christopher C. Thompson, MD, MSc

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Oral sedated endoscopy of the upper gastrointestinal tract as Esophagogastroduodenoscopy (EGD) has been time tested and effective, but poses enhanced risk in the bariatric population. In the adult population nasal rather than orally guided EGD is available without sedations. This is known as transnasal endoscopy (TNE). Adult studies have demonstrated its feasibility, more rapid implementation, a possibility for increased endoscopy access, and enhanced safety for its use in multiple upper gastrointestinal tract disease, however it has not been readily adopted in the United States using standard 5-6 mm transnasal endoscopes.

Generally, having only sedated oral upper tract endoscopy using a typical 9-10 mm endoscope available in the United States has created problems with increasing costs, delayed diagnosis, endoscopy access issues, and morbidity around upper gastrointestinal tract disease. In a bariatric and metabolic program this can also delay care and timely intervention to allow for weight loss and improved morbidity. The recent COVID-19 pandemic has also hindered access to general diagnostic endoscopy and the referrals from bariatric programs could also prevent access for other general diagnostic screening or surveillance endoscopy not in the bariatric population. Additionally, the total cost of a sedated EGD can exceed $10,000 due to the cost of anesthesia. In high-risk populations such as the elderly and individuals with increased body mass index (BMI), the use of endotracheal tubes and deep sedation can lead to aspiration, atelectasis, or pneumonia. Most recently Friedlander and Nguyen et al published reports on the increased use of sedation-free endoscopy using even smaller endoscopes for primarily Eosinophilic esophagitis (EoE) but also a variety of diseases. Additionally, DeBoer et al published on the use of TNE in bariatric endoscopic screening and showed success and lower costs in an adult population. EvoEndo, Inc. has developed and introduced an FDA cleared 3.5 mm, portable, single-use endoscopy system that enables transnasal endoscopy of the upper GI tract with mucosal biopsies. It has the potential to more broadly introduce enhanced sedation-free endoscopic options for high risk patients in need of endoscopic screening for bariatric conditions in the United States. This study aims to evaluate the introduction of sedation-free TNE to an ambulatory bariatric clinic and evaluate its impact on time to diagnosis, time to intervention, impact on patient (direct/indirect) and clinic costs (direct/indirect) and revenue and the provider/team experience introducing the system.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Christopher C. Thompson, MD, MSc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transnasal Endoscopy (TNE)
Unsedated endoscopic evaluation of the esophagus and stomach through the nose with a transnasal endoscope.
Device: Transnasal Endoscopy
Unsedated endoscopic evaluation through the nose.
Other Names:
  • TNE
Active Comparator: Sedated Esophagogastroduodenoscopy (EGD)
Sedated endoscopic evaluation of the esophagus and stomach through the mouth with a standard upper endoscope.
Procedure: Esophagogastroduodenoscopy
Sedated endoscopic evaluation through the mouth.
Other Names:
  • EGD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experience survey
Time Frame: Up 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
Up to 7 days post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient interest
Time Frame: Baseline
Assess the number of subjects who are asked versus enroll in the study
Baseline
Patient satisfaction - mGHAA-9
Time Frame: Up to 7 days post procedure
Satisfaction of subjects undergoing unsedated TNE using the EvoEndo Endoscopy System via the modified Group Health Association of America-9 survey (mGHAA-9)
Up to 7 days post procedure
Patient satisfaction - TNE Post-procedure evaluation
Time Frame: Up to 7 days post procedure
satisfaction of subjects undergoing unsedated TNE using the EvoEndo Endoscopy System via the Post Procedure Unsedated Transnasal Endoscopy Instrument
Up to 7 days post procedure
Duration of procedure
Time Frame: Up to 7 days post procedure
Assess duration in minutes of TNE (nose in/nose out)
Up to 7 days post procedure
Total Endoscopy Experience duration
Time Frame: Up to 7 days post procedure
Assess total duration in minutes of patient endoscopic experience (check in/check out)
Up to 7 days post procedure
Time to diagnosis
Time Frame: Baseline, Up to 30 days post procedure
Assess time from first clinic visit to provider diagnosis in days
Baseline, Up to 30 days post procedure
Biopsy sample adequacy
Time Frame: Up to 30 days post procedure
Pathology assessment of adequacy of biopsies when using TNE
Up to 30 days post procedure
Comparison of cost of TNE versus EGD
Time Frame: Up to 30 days post procedure
Assess averages charges and collections for an isolated oral sedated EGD or Esophagoscopy at the institution compared to the charges, collections, and cost for implementing TNE using the EvoEndo Endoscopy System.
Up to 30 days post procedure
Adverse Events
Time Frame: Up to 30 days post procedure
Assess provider reported adverse events of TNE
Up to 30 days post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christopher C. Thompson, MD, MSc

Collaborators

EvoEndo, Inc.

Investigators

  • Principal Investigator: Christopher C. Thompson, MD, MSc, Brigham and Womens Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 29, 2023

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023P002683

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD could be shared on a case by case basis with approval from the PI and fully executed institutional data sharing agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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