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Trans-nasal Endoscopy for Bariatric Patients

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the EvoEndo system, a very thin, single-use camera tube passed through the nose. It will study its use to check, treat, and follow up on problems in the upper digestive tract, such as the food pipe and stomach. It is for adults getting care at a weight-loss and metabolism clinic.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old but younger than 90.
  • You have been referred for a camera exam of your food pipe, stomach, or upper small intestine.
  • You get care at a weight-loss and metabolism clinic.

Who can't join

  • You are younger than 18.
  • A medical condition makes a camera exam through your mouth or nose unsafe for you.
  • You cannot give informed consent, meaning you cannot understand the study and agree to take part.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

MA