ObesityTNENCT06200961
Trans-nasal Endoscopy for Bariatric Patients
A study testing Transnasal Endoscopy and Esophagogastroduodenoscopy in people with Obesity and Obesity, Morbid, run by Christopher C. Thompson, MD, MSc at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obesity, Obesity, Morbid, Obese
- What is being tested?
- Transnasal Endoscopy and Esophagogastroduodenoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient <18 years of age
- Medically contraindicated to perform EGD or TNE
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Michele B. Ryan, MS, 6175258266, mryan@bwh.harvard.edu
Christopher C. Thompson, MD, MSc
About this study
Official title: Use of Sedation-Free Transnasal Endoscopy to Improve Access and Lower Costs of Endoscopic Evaluations in a Bariatric Medical and Surgical Program
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.
Read the 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.
- Conditions
- Obesity, Obesity, Morbid, Obese, GI Disorders, Gastrointestinal Diseases
- Being tested
- Transnasal Endoscopy, Esophagogastroduodenoscopy
- Keywords
- Transnasal Endoscopy (TNE), Esophagogastroduodenoscopy (EGD), Upper Endoscopy, Endoscopy
- Medical subject headings
- Obesity, Obesity, Morbid, Digestive System Diseases, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transnasal EndoscopyDevice
Also called TNE
Unsedated endoscopic evaluation through the nose.
EsophagogastroduodenoscopyProcedure or surgery
Also called EGD
Sedated endoscopic evaluation through the mouth.
| Study group | Role | What they receive |
|---|---|---|
| Transnasal Endoscopy (TNE) | Active comparator | Unsedated endoscopic evaluation of the esophagus and stomach through the nose with a transnasal endoscope. Receives: Device: Transnasal Endoscopy |
| Sedated Esophagogastroduodenoscopy (EGD) | Active comparator | Sedated endoscopic evaluation of the esophagus and stomach through the mouth with a standard upper endoscope. Receives: Procedure: Esophagogastroduodenoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience survey
Evaluate the experience of patients and provider teams utilizing sedation-free transnasal endoscopy for evaluation of upper gastrointestinal (GI) conditions
Measured: Up to 7 days post procedure
Secondary outcomes (9)
Patient interest
Assess the number of subjects who are asked versus enroll in the study
Measured: Baseline
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)
Measured: Up to 7 days post procedure
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
Measured: Up to 7 days post procedure
Duration of procedure
Assess duration in minutes of TNE (nose in/nose out)
Measured: Up to 7 days post procedure
Total Endoscopy Experience duration
Assess total duration in minutes of patient endoscopic experience (check in/check out)
Measured: Up to 7 days post procedure
Time to diagnosis
Assess time from first clinic visit to provider diagnosis in days
Measured: Baseline, Up to 30 days post procedure
Biopsy sample adequacy
Pathology assessment of adequacy of biopsies when using TNE
Measured: Up to 30 days post procedure
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.
Measured: Up to 30 days post procedure
Adverse Events
Assess provider reported adverse events of TNE
Measured: Up to 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start20 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Case Control
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christopher C. Thompson, MD, MSc
- Sponsor type
- University, hospital or other
- Collaborators
- EvoEndo, Inc.
- Responsible party
- Sponsor-investigator, Christopher C. Thompson, MD, MSc, Brigham and Women's Hospital
- Investigators
- Christopher C. Thompson, MD, MSc, Principal investigator, Brigham and Womens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200961
- Sponsor's protocol ID
- 2023P002683
- Acronym
- TNE
- Status last verified
- Jun 2026
- First submitted
- 13 Dec 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD could be shared on a case by case basis with approval from the PI and fully executed institutional data sharing agreement.
Publications
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.
PubMed 36529851Acosta 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.
PubMed 28242319American Societyfor Gastrointestinal Endoscopy Standards of Practice Committee; Evans JA, Muthusamy VR, Acosta RD, Bruining DH, Chandrasekhara V, Chathadi KV, Eloubeidi MA, Fanelli RD, Faulx AL, Fonkalsrud L, Khashab MA, Lightdale JR, Pasha SF, Saltzman JR, Shaukat A, Wang A, Stefanidis D, Richardson WS, Kothari SN, Cash BD. The role of endoscopy in the bariatric surgery patient. Gastrointest Endosc. 2015 May;81(5):1063-72. doi: 10.1016/j.gie.2014.09.044. Epub 2015 Feb 27. No abstract available.
PubMed 25733126Kolb 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.
PubMed 32777286Thrift 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.
PubMed 29671158Rubenstein 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.
PubMed 25957861Shaheen 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.
PubMed 35354777ASGE 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.
PubMed 31439127Muthusamy 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.
PubMed 35788412Dellon 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.
PubMed 23567357Furuta 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.
PubMed 22895393Dumortier 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.
PubMed 10049409Dumortier 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.
PubMed 17591468Birkner 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.
PubMed 12929058Mokhashi 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.
PubMed 14638337
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Sedation-Free Transnasal Endoscopy to Improve Access and Lower Costs of Endoscopic Evaluations in a Bariatric Medical and Surgical Program
- ClinicalTrials.gov ID
- NCT06200961
- Acronym / sponsor ID
- TNE / 2023P002683
- Conditions
- Obesity, Obesity, Morbid, Obese, GI Disorders, Gastrointestinal Diseases
- Keywords
- Transnasal Endoscopy (TNE), Esophagogastroduodenoscopy (EGD), Upper Endoscopy, Endoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Christopher C. Thompson, MD, MScUniversity, hospital or other
- Collaborators
- EvoEndo, Inc.
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case Control
| Arm | Type | Receives |
|---|---|---|
| Transnasal Endoscopy (TNE) | Active comparator | Device: Transnasal EndoscopyUnsedated endoscopic evaluation of the esophagus and stomach through the nose with a transnasal endoscope. |
| Sedated Esophagogastroduodenoscopy (EGD) | Active comparator | Procedure: EsophagogastroduodenoscopySedated endoscopic evaluation of the esophagus and stomach through the mouth with a standard upper endoscope. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patient <18 years of age
- Medically contraindicated to perform EGD or TNE
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transnasal EndoscopyAlso: TNEUnsedated endoscopic evaluation through the nose. | Device | Transnasal Endoscopy (TNE) |
| EsophagogastroduodenoscopyAlso: EGDSedated endoscopic evaluation through the mouth. | Procedure or surgery | Sedated Esophagogastroduodenoscopy (EGD) |
Primary outcome
Experience survey
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
9 secondary outcomes
Patient interest
Time frame: Baseline
Patient satisfaction - mGHAA-9
Time frame: Up to 7 days post procedure
Patient satisfaction - TNE Post-procedure evaluation
Time frame: Up to 7 days post procedure
Duration of procedure
Time frame: Up to 7 days post procedure
Total Endoscopy Experience duration
Time frame: Up to 7 days post procedure
Time to diagnosis
Time frame: Baseline, Up to 30 days post procedure
Biopsy sample adequacy
Time frame: Up to 30 days post procedure
Comparison of cost of TNE versus EGD
Time frame: Up to 30 days post procedure
Adverse Events
Time frame: Up to 30 days post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 36529851Slater 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.
- Background: PubMed 28242319Acosta 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.
- Background: PubMed 25733126American Societyfor Gastrointestinal Endoscopy Standards of Practice Committee; Evans JA, Muthusamy VR, Acosta RD, Bruining DH, Chandrasekhara V, Chathadi KV, Eloubeidi MA, Fanelli RD, Faulx AL, Fonkalsrud L, Khashab MA, Lightdale JR, Pasha SF, Saltzman JR, Shaukat A, Wang A, Stefanidis D, Richardson WS, Kothari SN, Cash BD. The role of endoscopy in the bariatric surgery patient. Gastrointest Endosc. 2015 May;81(5):1063-72. doi: 10.1016/j.gie.2014.09.044. Epub 2015 Feb 27. No abstract available.
- Background: PubMed 32777286Kolb 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.
- Background: PubMed 29671158Thrift 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.
- Background: PubMed 25957861Rubenstein 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.
- Background: PubMed 35354777Shaheen 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.
- Background: PubMed 31439127ASGE 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.
- Background: PubMed 35788412Muthusamy 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.
- Background: PubMed 23567357Dellon 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.
- Background: PubMed 22895393Furuta 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.
- Background: PubMed 10049409Dumortier 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.
- Individual participant dataSharing planned: No. IPD could be shared on a case by case basis with approval from the PI and fully executed institutional data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher C. Thompson, MD, MSc principal investigator
Brigham and Womens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transnasal Endoscopy and Esophagogastroduodenoscopy in people with Obesity and Obesity, Morbid, run by Christopher C. Thompson, MD, MSc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele B Ryan, MS (617-525-8266, mryan@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience survey (time frame: Up to 7 days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06200961, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.