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
NCT Number: NCT06200961
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
Location status: Recruiting
Christopher C. Thompson, MD, MSc
PRINCIPAL_INVESTIGATOR
Michele B. Ryan, MS
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Unsedated endoscopic evaluation through the nose.
Other names: TNE
Sedated endoscopic evaluation through the mouth.
Other names: EGD
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
Time frame: Baseline
Assess the number of subjects who are asked versus enroll in the study
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)
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
Time frame: Up to 7 days post procedure
Assess duration in minutes of TNE (nose in/nose out)
Time frame: Up to 7 days post procedure
Assess total duration in minutes of patient endoscopic experience (check in/check out)
Time frame: Baseline, Up to 30 days post procedure
Assess time from first clinic visit to provider diagnosis in days
Time frame: Up to 30 days post procedure
Pathology assessment of adequacy of biopsies when using TNE
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.
Time frame: Up to 30 days post procedure
Assess provider reported adverse events of TNE
Contact information is provided by the study sponsor or research team.
Christopher C. Thompson, MD, MSc
Other
Use of Sedation-Free Transnasal Endoscopy to Improve Access and Lower Costs of Endoscopic Evaluations in a Bariatric Medical and Surgical Program
Acronym: TNE
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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