Transnasal Endoscopy for Obesity
(TNE Trial)
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?
Is transnasal endoscopy safe for humans?
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 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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo unsedated transnasal endoscopy (TNE) or sedated esophagogastroduodenoscopy (EGD) for evaluation of the upper gastrointestinal tract
Follow-up
Participants are monitored for safety, effectiveness, and satisfaction after the procedure
Treatment Details
Interventions
- Esophagogastroduodenoscopy
- Transnasal Endoscopy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Christopher C. Thompson, MD, MSc
Lead Sponsor
EvoEndo, Inc.
Collaborator