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Recruiting

NCT Number: NCT06200961

Trans-nasal Endoscopy for Bariatric Patients

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.

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Christopher C. Thompson, MD, MSc

PRINCIPAL_INVESTIGATOR

Michele B. Ryan, MS

CONTACT

[email protected]

6175258266

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Transnasal Endoscopy

Device

Unsedated endoscopic evaluation through the nose.

Other names: TNE

Esophagogastroduodenoscopy

Procedure

Sedated endoscopic evaluation through the mouth.

Other names: EGD

Primary outcomes

  1. 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

Secondary outcomes

  1. Patient interest

    Time frame: Baseline

    Assess the number of subjects who are asked versus enroll in the study

  2. 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)

  3. 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

  4. Duration of procedure

    Time frame: Up to 7 days post procedure

    Assess duration in minutes of TNE (nose in/nose out)

  5. 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)

  6. Time to diagnosis

    Time frame: Baseline, Up to 30 days post procedure

    Assess time from first clinic visit to provider diagnosis in days

  7. Biopsy sample adequacy

    Time frame: Up to 30 days post procedure

    Pathology assessment of adequacy of biopsies when using TNE

  8. 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.

  9. Adverse Events

    Time frame: Up to 30 days post procedure

    Assess provider reported adverse events of TNE

Study contacts

Contact information is provided by the study sponsor or research team.

Michele B Ryan, MS

CONTACT

[email protected]

617-525-8266

Sponsors and collaborators

Lead sponsor

Christopher C. Thompson, MD, MSc

Other

Collaborators

  • EvoEndo, Inc.

Registry information

Official study title

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

Acronym: TNE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 11, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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