Clinical trial NCT06200961: Trans-nasal Endoscopy for Bariatric Patients
Official title: Use of Sedation-Free Transnasal Endoscopy to Improve Access and Lower Costs of Endoscopic Evaluations in a Bariatric Medical and Surgical Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Obesity, Morbid
Obese
GI Disorders
Gastrointestinal Diseases
Keywords: Transnasal Endoscopy (TNE)
Esophagogastroduodenoscopy (EGD)
Upper Endoscopy
Endoscopy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: EvoEndo, Inc.
First posted: 2024-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case Control
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Experience survey
timeFrame: Up to 7 days post procedure
Secondary outcomes:
measure: Patient interest
timeFrame: Baseline
measure: Patient satisfaction - mGHAA-9
timeFrame: Up to 7 days post procedure
measure: Patient satisfaction - TNE Post-procedure evaluation
timeFrame: Up to 7 days post procedure
measure: Duration of procedure
timeFrame: Up to 7 days post procedure
measure: Total Endoscopy Experience duration
timeFrame: Up to 7 days post procedure
measure: Time to diagnosis
timeFrame: Baseline, Up to 30 days post procedure
measure: Biopsy sample adequacy
timeFrame: Up to 30 days post procedure
measure: Comparison of cost of TNE versus EGD
timeFrame: Up to 30 days post procedure
measure: Adverse Events
timeFrame: Up to 30 days post procedure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Womens Hospital
name: Christopher C. Thompson, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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