Trans-nasal Endoscopy for Bariatric Patients

Not Applicable

Recruiting

• Conditions: Obesity; Obesity, Morbid; Obese; GI Disorders; Gastrointestinal Diseases
• Interventions: Procedure: Esophagogastroduodenoscopy; Device: Transnasal Endoscopy

• Registration Number: NCT06200961
• Lead Sponsor: Christopher C. Thompson, MD, MSc

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.

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 Timeline

• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2023-12-29
• Study First Posted: 2024-01-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05
• Study Start: 2025-04
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sedated Esophagogastroduodenoscopy (EGD)	Esophagogastroduodenoscopy	Sedated endoscopic evaluation of the esophagus and stomach through the mouth with a standard upper endoscope.
Transnasal Endoscopy (TNE)	Transnasal Endoscopy	Unsedated endoscopic evaluation of the esophagus and stomach through the nose with a transnasal endoscope.

Primary Outcome Measures

Name	Time	Method
Experience survey	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 Outcome Measures

Name	Time	Method
Adverse Events	Up to 30 days post procedure	Assess provider reported adverse events of TNE
Patient interest	Baseline	Assess the number of subjects who are asked versus enroll in the study
Duration of procedure	Up to 7 days post procedure	Assess duration in minutes of TNE (nose in/nose out)
Comparison of cost of TNE versus EGD	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.
Total Endoscopy Experience duration	Up to 7 days post procedure	Assess total duration in minutes of patient endoscopic experience (check in/check out)
Time to diagnosis	Baseline, Up to 30 days post procedure	Assess time from first clinic visit to provider diagnosis in days
Patient satisfaction - mGHAA-9	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)
Patient satisfaction - TNE Post-procedure evaluation	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
Biopsy sample adequacy	Up to 30 days post procedure	Pathology assessment of adequacy of biopsies when using TNE

Trial Locations

Locations (1)

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