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Procedure

Transnasal Endoscopy for Obesity (TNE Trial)

N/A
Waitlist Available
Research Sponsored by Christopher C. Thompson, MD, MSc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient 18 years of age and less than 90 years of age clinically referred for esophagoscopy, gastroscopy, or esophagogastroduodenoscopy (EGD)
Be older than 18 years old
Must not have
Medically contraindicated to perform EGD or TNE
Patient <18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying a new type of endoscopy system called EvoEndo to see if it can be used to diagnose and treat diseases in the upper gastrointestinal tract of people who have had bariat

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort or pain due to the slim scope used in transnasal endoscopy, nosebleeds, sore throat, or other complications associated with standard endoscopic procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 89 years old and referred for an upper GI endoscopy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot undergo an EGD or TNE due to medical reasons.
Select...
I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Experience survey
Secondary study objectives
Adverse Events
Biopsy sample adequacy
Comparison of cost of TNE versus EGD
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

EvoEndo, Inc.UNKNOWN
1 Previous Clinical Trials
30 Total Patients Enrolled
Christopher C. Thompson, MD, MScLead Sponsor
5 Previous Clinical Trials
5,146 Total Patients Enrolled
2 Trials studying Obesity
5,006 Patients Enrolled for Obesity
~67 spots leftby Oct 2025
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