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临床试验/NCT06200961
NCT06200961招募中不适用

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

Christopher C. Thompson, MD, MSc2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
Experience survey

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Sedated Esophagogastroduodenoscopy (EGD)

Active Comparator

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

干预措施: Esophagogastroduodenoscopy (Procedure)

Transnasal Endoscopy (TNE)

Active Comparator

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

干预措施: Transnasal Endoscopy (Device)

结局指标

主要结局

Experience survey

时间窗: 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

次要结局

  • Patient interest(Baseline)
  • Duration of procedure(Up to 7 days post procedure)
  • Comparison of cost of TNE versus EGD(Up to 30 days post procedure)
  • Total Endoscopy Experience duration(Up to 7 days post procedure)
  • Adverse Events(Up to 30 days post procedure)
  • Time to diagnosis(Baseline, Up to 30 days post procedure)
  • Patient satisfaction - mGHAA-9(Up to 7 days post procedure)
  • Patient satisfaction - TNE Post-procedure evaluation(Up to 7 days post procedure)
  • Biopsy sample adequacy(Up to 30 days post procedure)

研究者

发起方
Christopher C. Thompson, MD, MSc
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Christopher C. Thompson, MD, MSc

Director of Endoscopy

Brigham and Women's Hospital

研究点 (2)

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