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Procedure

Transnasal Endoscopy (TNE) 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days post procedure

Awards & highlights

TNE Trial 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.Check my eligibility

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.See study design

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.

TNE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 89 years old and referred for an upper GI endoscopy.

TNE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Experience survey

Secondary outcome measures

Adverse Events

Biopsy sample adequacy

Comparison of cost of TNE versus EGD

+6 more

TNE 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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Christopher C. Thompson, MD, MScLead Sponsor

2 Previous Clinical Trials

5,006 Total Patients Enrolled

2 Trials studying Obesity

5,006 Patients Enrolled for Obesity

EvoEndo, Inc.UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing opportunities for patients to participate in this research study?

"According to the information available on clinicaltrials.gov, this specific trial is not actively seeking participants at the moment. The initial posting date of this trial was February 1st, 2024, and it was last edited on December 29th, 2023. However, it's worth noting that there are currently a total of 1099 other trials enrolling patients."

Answered by AI

Which individuals are eligible to take part in this research study?

"To be eligible for participation in this study, individuals must meet the criteria of having a body mass index (BMI) indicating obesity and fall within the age range of 18 to 90. The trial aims to recruit approximately 100 patients."

Answered by AI