Trans-nasal Endoscopy for Bariatric Patients

Obesity Clinical Trial

— TNE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06200961
• Other study ID #: 2023P002683
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Brigham and Women's Hospital
• Contact: Michele B Ryan, MS
• Phone: 617-525-8266
• Email: mryan[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 30, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• GI Disorders
• Obese
• Obesity
• Obesity, Morbid

Intervention

Device:
• Transnasal Endoscopy
Unsedated endoscopic evaluation through the nose.

Procedure:
• Esophagogastroduodenoscopy
Sedated endoscopic evaluation through the mouth.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Christopher C. Thompson, MD, MSc	EvoEndo, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (28)

Acosta A, Streett S, Kroh MD, Cheskin LJ, Saunders KH, Kurian M, Schofield M, Barlow SE, Aronne L. White Paper AGA: POWER - Practice Guide on Obesity and Weight Management, Education, and Resources. Clin Gastroenterol Hepatol. 2017 May;15(5):631-649.e10. doi: 10.1016/j.cgh.2016.10.023. Epub 2017 Feb 27. — View Citation

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ASGE STANDARDS OF PRACTICE COMMITTEE; Qumseya B, Sultan S, Bain P, Jamil L, Jacobson B, Anandasabapathy S, Agrawal D, Buxbaum JL, Fishman DS, Gurudu SR, Jue TL, Kripalani S, Lee JK, Khashab MA, Naveed M, Thosani NC, Yang J, DeWitt J, Wani S; ASGE Standards of Practice Committee Chair. ASGE guideline on screening and surveillance of Barrett's esophagus. Gastrointest Endosc. 2019 Sep;90(3):335-359.e2. doi: 10.1016/j.gie.2019.05.012. No abstract available. — View Citation

ASGE Technology Committee; Rodriguez SA, Banerjee S, Desilets D, Diehl DL, Farraye FA, Kaul V, Kwon RS, Mamula P, Pedrosa MC, Varadarajulu S, Song LM, Tierney WM. Ultrathin endoscopes. Gastrointest Endosc. 2010 May;71(6):893-8. doi: 10.1016/j.gie.2010.01.022. No abstract available. — View Citation

Birkner B, Fritz N, Schatke W, Hasford J. A prospective randomized comparison of unsedated ultrathin versus standard esophagogastroduodenoscopy in routine outpatient gastroenterology practice: does it work better through the nose? Endoscopy. 2003 Aug;35(8):647-51. doi: 10.1055/s-2003-41523. — View Citation

DeBoer AM, Mellion KM, Frankki SM, Kallies KJ, Grover BT, Pfeiffer JD, Kothari SN. Pre-screening for bariatric surgery patients: comparative effectiveness of transnasal endoscopy versus esophagogastroduodenoscopy. Surg Endosc. 2021 Aug;35(8):4153-4159. doi: 10.1007/s00464-020-07892-y. Epub 2020 Aug 14. — View Citation

Dellon ES, Gonsalves N, Hirano I, Furuta GT, Liacouras CA, Katzka DA; American College of Gastroenterology. ACG clinical guideline: Evidenced based approach to the diagnosis and management of esophageal eosinophilia and eosinophilic esophagitis (EoE). Am J Gastroenterol. 2013 May;108(5):679-92; quiz 693. doi: 10.1038/ajg.2013.71. Epub 2013 Apr 9. — View Citation

Dumortier J, Josso C, Roman S, Fumex F, Lepilliez V, Prost B, Lot M, Guillaud O, Petit-Laurent F, Lapalus MG, Ponchon T. Prospective evaluation of a new ultrathin one-plane bending videoendoscope for transnasal EGD: a comparative study on performance and tolerance. Gastrointest Endosc. 2007 Jul;66(1):13-9. doi: 10.1016/j.gie.2006.11.058. — View Citation

Dumortier J, Ponchon T, Scoazec JY, Moulinier B, Zarka F, Paliard P, Lambert R. Prospective evaluation of transnasal esophagogastroduodenoscopy: feasibility and study on performance and tolerance. Gastrointest Endosc. 1999 Mar;49(3 Pt 1):285-91. doi: 10.1016/s0016-5107(99)70002-7. — View Citation

Friedlander JA, DeBoer EM, Soden JS, Furuta GT, Menard-Katcher CD, Atkins D, Fleischer DM, Kramer RE, Deterding RR, Capocelli KE, Prager JD. Unsedated transnasal esophagoscopy for monitoring therapy in pediatric eosinophilic esophagitis. Gastrointest Endosc. 2016 Feb;83(2):299-306.e1. doi: 10.1016/j.gie.2015.05.044. Epub 2015 Jul 2. — View Citation

Furuta GT, Kagalwalla AF, Lee JJ, Alumkal P, Maybruck BT, Fillon S, Masterson JC, Ochkur S, Protheroe C, Moore W, Pan Z, Amsden K, Robinson Z, Capocelli K, Mukkada V, Atkins D, Fleischer D, Hosford L, Kwatia MA, Schroeder S, Kelly C, Lovell M, Melin-Aldana H, Ackerman SJ. The oesophageal string test: a novel, minimally invasive method measures mucosal inflammation in eosinophilic oesophagitis. Gut. 2013 Oct;62(10):1395-405. doi: 10.1136/gutjnl-2012-303171. Epub 2012 Aug 15. — View Citation

Gardner JG, Feld LD. The impact of COVID-19 on endoscopy and cancer screening: a focus on access and equity. Therap Adv Gastroenterol. 2023 May 10;16:17562848231173334. doi: 10.1177/17562848231173334. eCollection 2023. — View Citation

Grant RK, Brindle WM, Robertson AR, Kalla R, Plevris JN. Unsedated Transnasal Endoscopy: A Safe, Well-Tolerated and Accurate Alternative to Standard Diagnostic Peroral Endoscopy. Dig Dis Sci. 2022 Jun;67(6):1937-1947. doi: 10.1007/s10620-022-07432-9. Epub 2022 Mar 3. — View Citation

Hu CT. Gauze pledgetting versus endoscopic-guided aerosolized spray for nasal anesthesia before transnasal EGD: a prospective, randomized study. Gastrointest Endosc. 2010 Jan;71(1):11-20. doi: 10.1016/j.gie.2009.06.016. Epub 2009 Sep 12. — View Citation

Kolb JM, Han S, Scott FI, Murphy CC, Hosokawa P, Wani S; Early Onset Esophageal Adenocarcinoma Study Group. Early-Onset Esophageal Adenocarcinoma Presents With Advanced-Stage Disease But Has Improved Survival Compared With Older Individuals. Gastroenterology. 2020 Dec;159(6):2238-2240.e4. doi: 10.1053/j.gastro.2020.08.002. Epub 2020 Aug 8. No abstract available. — View Citation

Lieber SR, Heller BJ, Martin CF, Howard CW, Crockett S. Complications of Anesthesia Services in Gastrointestinal Endoscopic Procedures. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2118-2127.e4. doi: 10.1016/j.cgh.2019.10.011. Epub 2019 Oct 14. — View Citation

Lin LF, Shen HC. Unsedated transnasal percutaneous endoscopic gastrostomy carried out by a single physician. Dig Endosc. 2013 Mar;25(2):130-5. doi: 10.1111/j.1443-1661.2012.01350.x. Epub 2012 Jul 10. — View Citation

Mokhashi MS, Wildi SM, Glenn TF, Wallace MB, Jost C, Gumustop B, Kim CY, Cotton PB, Hawes RH. A prospective, blinded study of diagnostic esophagoscopy with a superthin, stand-alone, battery-powered esophagoscope. Am J Gastroenterol. 2003 Nov;98(11):2383-9. doi: 10.1111/j.1572-0241.2003.08701.x. — View Citation

Mulcahy HE, Riches A, Kiely M, Farthing MJ, Fairclough PD. A prospective controlled trial of an ultrathin versus a conventional endoscope in unsedated upper gastrointestinal endoscopy. Endoscopy. 2001 Apr;33(4):311-6. doi: 10.1055/s-2001-13692. — View Citation

Muthusamy VR, Wani S, Gyawali CP, Komanduri S; CGIT Barrett's Esophagus Consensus Conference Participants. AGA Clinical Practice Update on New Technology and Innovation for Surveillance and Screening in Barrett's Esophagus: Expert Review. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2696-2706.e1. doi: 10.1016/j.cgh.2022.06.003. Epub 2022 Jul 3. — View Citation

Nguyen N, Lavery WJ, Capocelli KE, Smith C, DeBoer EM, Deterding R, Prager JD, Leinwand K, Kobak GE, Kramer RE, Menard-Katcher C, Furuta GT, Atkins D, Fleischer D, Greenhawt M, Friedlander JA. Transnasal Endoscopy in Unsedated Children With Eosinophilic Esophagitis Using Virtual Reality Video Goggles. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2455-2462. doi: 10.1016/j.cgh.2019.01.023. Epub 2019 Jan 29. — View Citation

Nguyen N, Mark J, Furuta GT. Emerging Role of Transnasal Endoscopy in Children and Adults. Clin Gastroenterol Hepatol. 2022 Mar;20(3):501-504. doi: 10.1016/j.cgh.2021.11.021. Epub 2021 Dec 16. No abstract available. — View Citation

Pouwels S, Buise MP, Twardowski P, Stepaniak PS, Proczko M. Obesity Surgery and Anesthesiology Risks: a Review of Key Concepts and Related Physiology. Obes Surg. 2019 Aug;29(8):2670-2677. doi: 10.1007/s11695-019-03952-y. — View Citation

Rubenstein JH, Shaheen NJ. Epidemiology, Diagnosis, and Management of Esophageal Adenocarcinoma. Gastroenterology. 2015 Aug;149(2):302-17.e1. doi: 10.1053/j.gastro.2015.04.053. Epub 2015 May 7. — View Citation

Shaheen NJ, Falk GW, Iyer PG, Souza RF, Yadlapati RH, Sauer BG, Wani S. Diagnosis and Management of Barrett's Esophagus: An Updated ACG Guideline. Am J Gastroenterol. 2022 Apr 1;117(4):559-587. doi: 10.14309/ajg.0000000000001680. — View Citation

Slater BJ, Collings A, Dirks R, Gould JC, Qureshi AP, Juza R, Rodriguez-Luna MR, Wunker C, Kohn GP, Kothari S, Carslon E, Worrell S, Abou-Setta AM, Ansari MT, Athanasiadis DI, Daly S, Dimou F, Haskins IN, Hong J, Krishnan K, Lidor A, Litle V, Low D, Petrick A, Soriano IS, Thosani N, Tyberg A, Velanovich V, Vilallonga R, Marks JM. Multi-society consensus conference and guideline on the treatment of gastroesophageal reflux disease (GERD). Surg Endosc. 2023 Feb;37(2):781-806. doi: 10.1007/s00464-022-09817-3. Epub 2022 Dec 18. — View Citation

Thrift AP. Barrett's Esophagus and Esophageal Adenocarcinoma: How Common Are They Really? Dig Dis Sci. 2018 Aug;63(8):1988-1996. doi: 10.1007/s10620-018-5068-6. — View Citation

Yagi J, Adachi K, Arima N, Tanaka S, Ose T, Azumi T, Sasaki H, Sato M, Kinoshita Y. A prospective randomized comparative study on the safety and tolerability of transnasal esophagogastroduodenoscopy. Endoscopy. 2005 Dec;37(12):1226-31. doi: 10.1055/s-2005-921037. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experience survey	Evaluate the experience of patients and provider teams utilizing sedation-free transnasal endoscopy for evaluation of upper gastrointestinal (GI) conditions	Up to 7 days post procedure
Secondary	Patient interest	Assess the number of subjects who are asked versus enroll in the study	Baseline
Secondary	Patient satisfaction - mGHAA-9	Satisfaction of subjects undergoing unsedated TNE using the EvoEndo Endoscopy System via the modified Group Health Association of America-9 survey (mGHAA-9)	Up to 7 days post procedure
Secondary	Patient satisfaction - TNE Post-procedure evaluation	satisfaction of subjects undergoing unsedated TNE using the EvoEndo Endoscopy System via the Post Procedure Unsedated Transnasal Endoscopy Instrument	Up to 7 days post procedure
Secondary	Duration of procedure	Assess duration in minutes of TNE (nose in/nose out)	Up to 7 days post procedure
Secondary	Total Endoscopy Experience duration	Assess total duration in minutes of patient endoscopic experience (check in/check out)	Up to 7 days post procedure
Secondary	Time to diagnosis	Assess time from first clinic visit to provider diagnosis in days	Baseline, Up to 30 days post procedure
Secondary	Biopsy sample adequacy	Pathology assessment of adequacy of biopsies when using TNE	Up to 30 days post procedure
Secondary	Comparison of cost of TNE versus EGD	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.	Up to 30 days post procedure
Secondary	Adverse Events	Assess provider reported adverse events of TNE	Up to 30 days post procedure