Transnasal Endoscopy for Obesity

(TNE Trial)

Overseen By Michele B Ryan, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Christopher C. Thompson, MD, MSc

Disqualifiers: Under 18, Medically contraindicated, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 7 days

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ultra-slim endoscope for examining the upper digestive tract in individuals with obesity-related issues. It compares two methods: transnasal endoscopy, which uses a small, flexible tube through the nose without sedation, and esophagogastroduodenoscopy, a traditional sedated procedure through the mouth. The researchers aim to determine if the new method is safer, more affordable, and easier to access. Suitable participants are adults referred for specific digestive tract exams and receiving care at a metabolic or bariatric clinic. As an unphased trial, this study provides a unique opportunity to advance medical procedures that could enhance patient comfort and accessibility.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the EvoEndo Endoscopy system is safe for evaluating upper gastrointestinal tract diseases in the bariatric population?

Research has shown that transnasal endoscopy (TNE) is a safe and well-tolerated procedure. It serves as a good alternative to the traditional method, which involves inserting a scope through the mouth. TNE, performed through the nose, does not require sedation, reducing the risk of complications, particularly for overweight patients who face higher risks with sedated procedures.

One study highlighted that TNE is safer for these patients and suggested that TNE may increase accessibility to endoscopy because it is quicker and less expensive than the traditional method. Another study found TNE both safe and effective, making it a promising option for those needing endoscopic evaluations.

Overall, TNE is generally well-tolerated and poses fewer risks than the sedated option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transnasal endoscopy for obesity because it offers a less invasive and more comfortable alternative to the traditional sedated esophagogastroduodenoscopy (EGD). Unlike EGD, which requires sedation and is performed through the mouth, transnasal endoscopy (TNE) is done without sedation and uses a thin endoscope inserted through the nose. This approach not only reduces the need for anesthesia but also allows for a quicker recovery time, making it more convenient for patients. The potential for TNE to provide effective obesity assessment with less hassle is what makes this technique particularly promising.

What evidence suggests that the EvoEndo Endoscopy system is effective for evaluating upper gastrointestinal tract diseases in the bariatric population?

This trial will compare Transnasal Endoscopy (TNE) with Sedated Esophagogastroduodenoscopy (EGD) for examining the upper part of the digestive system. Research has shown that TNE, one of the treatments participants may receive, is a promising method, particularly for patients who have undergone weight-loss surgery. Studies have found that TNE can significantly reduce costs, with a 65% decrease in supplies needed and a 92% drop in medication costs compared to traditional methods. Previous evidence suggests that TNE is safe and effective for these examinations. Additionally, TNE can be performed without sedation, allowing for quicker and safer recovery. Overall, TNE has demonstrated potential in providing effective care for patients needing these evaluations. ^{2 4 5 6 7}

Who Is on the Research Team?

Christopher Thompson, MD

Principal Investigator

Brigham and Womens Hospital

Are You a Good Fit for This Trial?

This trial is for bariatric patients who need an evaluation of their upper gastrointestinal tract. Participants should be adults with obesity and related gastrointestinal conditions, but specific inclusion and exclusion criteria are not detailed.

Inclusion Criteria

Cared for in metabolic and bariatric clinic

Exclusion Criteria

I cannot undergo an EGD or TNE due to medical reasons.

I am under 18 years old.

Inability to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo unsedated transnasal endoscopy (TNE) or sedated esophagogastroduodenoscopy (EGD) for evaluation of the upper gastrointestinal tract

Up to 7 days

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and satisfaction after the procedure

Up to 30 days

What Are the Treatments Tested in This Trial?

Interventions

• Esophagogastroduodenoscopy
• Transnasal Endoscopy

Trial Overview

The study is testing the EvoEndo Endoscopy system, which includes a new ultra-slim, single-use endoscope designed for transnasal procedures to see if it's effective in evaluating upper GI diseases in obese patients.

How Is the Trial Designed?

Group I: Transnasal Endoscopy (TNE) Active Control 1 Intervention

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

Group II: Sedated Esophagogastroduodenoscopy (EGD) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Christopher C. Thompson, MD, MSc

Lead Sponsor

Trials

6

Recruited

5,300+

EvoEndo, Inc.

Collaborator

Trials

2

Recruited

130+

Published Research Related to This Trial

In a study of 241 patients with chronic rhinosinusitis undergoing endoscopic sinus surgery, 41% were found to have comorbid obesity, which was associated with higher rates of other health issues like diabetes and asthma.

While all patients showed significant improvements in quality of life after surgery, those with obesity experienced less relative improvement compared to normal weight patients, indicating that obesity may impact the effectiveness of the surgery on quality of life outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does comorbid obesity impact quality of life outcomes in patients undergoing endoscopic sinus surgery? Steele, TO., Mace, JC., DeConde, AS., et al.[2018]

Transnasal endoscopy (TNE) is significantly more comfortable and better accepted by patients compared to standard upper endoscopy (SOGD), with a mean comfort score of 7.3 for TNE versus 5.3 for SOGD.

TNE also results in less cardiovascular stress and gagging during the procedure, making it a preferable option for patients with cardiorespiratory issues, while still providing adequate biopsy samples for diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised clinical study: comparison of acceptability, patient tolerance, cardiac stress and endoscopic views in transnasal and transoral endoscopy under local anaesthetic. Alexandridis, E., Inglis, S., McAvoy, NC., et al.[2022]

Endoscopic techniques for weight loss present a promising alternative to traditional surgical methods, especially in the context of the growing obesity epidemic in Western countries.

Bariatric and metabolic endoscopy has led to the creation of several safe and effective technologies that can be utilized by endoscopists to manage obesity, leveraging their expertise in gastrointestinal physiology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of bariatric and metabolic endoscopy interventions. Tawadros, A., Makar, M., Kahaleh, M., et al.[2020]

Bariatric surgical programs are on the rise due to increasing obesity rates, highlighting the need for specialized endoscopy units to accommodate the unique requirements of obese patients.

Endoscopy plays a crucial role in evaluating bariatric patients, managing postoperative complications, and developing new endoscopic therapies, necessitating careful planning and resource allocation in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopy unit considerations in the care of obese patients. Ginsberg, GG., Pickett-Blakely, O.[2011]

Endoscopic therapies for obesity are becoming more common, but their clinical effectiveness and safety are still not well understood, highlighting the need for more research in this area.

This review focuses on updating the knowledge about various endoscopic treatments for obesity, emphasizing their technical details and the evidence supporting their use in real-world clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic treatments of obesity and metabolic disease: are we there yet? Abu-Dayyeh, BK., Sarmiento, R., Rajan, E., et al.[2016]

Propanidid has been shown to be a safe and effective sedation option for endoscopic procedures in patients with super obesity, addressing the challenges associated with sedation in this population.

The case report highlights the potential of propanidid to minimize the risk of unplanned events during endoscopy, which is particularly important for obese patients who may face higher sedation-related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sedation in a patient with super obesity: Case report. Olvera-Martínez, R., Loredo-García, NG., Mutis-Ospino, B.[2021]

A study involving 132 super obese patients (BMI ≥ 50) and 132 non-obese controls found that general endoscopic procedures can be safely performed with moderate sedation, achieving a 100% completion rate for both groups.

Super obese patients required higher doses of sedation medications and experienced a higher rate of brief intra-procedure hypoxia (5% vs 0% in controls), but there were no differences in delayed adverse events between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Moderate Sedation in Super Obese Patients Undergoing Lower and Upper GI Endoscopy: a Case-Control Study. Benson, M., Hubers, J., Caldis, M., et al.[2021]

A retrospective analysis of 1020 patients treated for bariatric surgery adverse events (AEs) from 2012 to 2020 showed that endoscopic treatments, particularly using pigtail stents and dilations, were effective, achieving clinical success rates of 86.1% for leaks and 77.2% for fistulas.

Early endoscopic intervention significantly improved clinical success rates, with a 1% increased risk of needing redo-surgery for every 10-day delay in treatment, highlighting the importance of timely management of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Management of Bariatric Surgery Complications According to a Standardized Algorithm. Spota, A., Cereatti, F., Granieri, S., et al.[2021]

Endoscopic management is a key first-line approach for addressing adverse events following bariatric surgery, such as ulcers, stenoses, and leaks, utilizing various devices like balloon dilators and stents.

This method is less invasive compared to traditional surgical interventions and often requires a multidisciplinary team, indicating its growing importance in the evolving treatment algorithms for bariatric surgery complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic devices and techniques for the management of bariatric surgical adverse events (with videos). Schulman, AR., Watson, RR., Abu Dayyeh, BK., et al.[2021]

Obese patients face unique challenges during endoscopic procedures, requiring endoscopists to be aware of specific risks associated with their condition.

The article discusses the endoscopic management of patients who have undergone bariatric surgery and explores the future role of endoscopy in treating obesity-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopy in the obese patient. Schreiner, MA., Fennerty, MB.[2010]

In a study of 95,251 adults undergoing bariatric surgery, Roux-en-Y gastric bypass (RYGB) had the highest rate of 30-day adverse events (3.8%) compared to adjustable gastric banding (AGB) and sleeve gastrectomy (SG), which had rates of 3.1% and 2.8%, respectively.

RYGB also showed higher hospitalization rates and mortality compared to AGB and SG, indicating that while RYGB may be effective, it carries more immediate and long-term risks than the other procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions and Operations after Bariatric Surgery in a Health Plan Research Network Cohort from the PCORnet, the National Patient-Centered Clinical Research Network. Ma, Q., Shambhu, S., Arterburn, DE., et al.[2021]

Transnasal endoscopy (TNE) is better tolerated than standard endoscopy, with discomfort mainly during insertion, which can be alleviated with topical anesthesia, making it a promising option for patients, especially the elderly or those with multiple health issues.

TNE has a similar diagnostic yield for conditions like Barrett's esophagus and gastric cancer compared to traditional methods, but its accuracy for detecting small early gastric malignancies needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transnasal endoscopy: no gagging no panic! Parker, C., Alexandridis, E., Plevris, J., et al.[2022]

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A retrospective, propensity score-matched study - PMC

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Transnasal Endoscopy for Obesity (TNE Trial)

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Overweight individuals have a greater risk of cardiorespiratory complications during endoscopy under sedation. This study aimed to investigate the feasibility, ...

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Patients with excess weight have a higher risk of cardiorespiratory complications during this procedure, being that the transnasal endoscopy ( ...