100 Participants Needed

Transnasal Endoscopy for Obesity

(TNE Trial)

MB
MB
Overseen ByMichele B Ryan, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Christopher C. Thompson, MD, MSc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Esophagogastroduodenoscopy, Transnasal Endoscopy for obesity?

Endoscopic therapies have been increasingly used to treat obesity and its complications, with some evidence suggesting their usefulness in clinical practice. These therapies are part of a growing field aimed at managing obesity through less invasive means than traditional surgery.12345

Is transnasal endoscopy safe for humans?

Research shows that endoscopic procedures, including transnasal endoscopy, are generally safe for humans, even in super obese patients, when moderate sedation is used. However, sedation can pose challenges, and careful monitoring is important to prevent serious events.56789

How is transnasal endoscopy different from other obesity treatments?

Transnasal endoscopy (TNE) is unique because it uses an ultrathin scope inserted through the nose, which can be more comfortable and less stressful for patients compared to traditional methods that go through the mouth. This approach may reduce the need for sedation, which is particularly beneficial for obese patients who face higher risks during sedated procedures.25101112

What is the purpose of this trial?

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.

Research Team

Christopher C. Thompson, MD - Brigham ...

Christopher Thompson, MD

Principal Investigator

Brigham and Womens Hospital

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Active Control
Group I: Transnasal Endoscopy (TNE)Active Control1 Intervention
Unsedated endoscopic evaluation of the esophagus and stomach through the nose with a transnasal endoscope.
Group II: Sedated Esophagogastroduodenoscopy (EGD)Active Control1 Intervention
Sedated endoscopic evaluation of the esophagus and stomach through the mouth with a standard upper endoscope.

Find a Clinic Near You

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+

Findings from Research

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.
Endoscopy unit considerations in the care of obese patients.Ginsberg, GG., Pickett-Blakely, O.[2011]
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.
Endoscopy in the obese patient.Schreiner, MA., Fennerty, MB.[2010]
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.
Does comorbid obesity impact quality of life outcomes in patients undergoing endoscopic sinus surgery?Steele, TO., Mace, JC., DeConde, AS., et al.[2018]

References

Endoscopy unit considerations in the care of obese patients. [2011]
Endoscopy in the obese patient. [2010]
Does comorbid obesity impact quality of life outcomes in patients undergoing endoscopic sinus surgery? [2018]
Endoscopic treatments of obesity and metabolic disease: are we there yet? [2016]
Sedation in a patient with super obesity: Case report. [2021]
Endoscopic Management of Bariatric Surgery Complications According to a Standardized Algorithm. [2021]
Endoscopic devices and techniques for the management of bariatric surgical adverse events (with videos). [2021]
Safety and Efficacy of Moderate Sedation in Super Obese Patients Undergoing Lower and Upper GI Endoscopy: a Case-Control Study. [2021]
Interventions and Operations after Bariatric Surgery in a Health Plan Research Network Cohort from the PCORnet, the National Patient-Centered Clinical Research Network. [2021]
Randomised clinical study: comparison of acceptability, patient tolerance, cardiac stress and endoscopic views in transnasal and transoral endoscopy under local anaesthetic. [2022]
Transnasal endoscopy: no gagging no panic! [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Overview of bariatric and metabolic endoscopy interventions. [2020]
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