500 Participants Needed

Diagnostic Tests for Detecting Barrett's Esophagus

Recruiting at 1 trial location
AC
Overseen ByAmitabh Chak, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Case Comprehensive Cancer Center
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 does not specify if you need to stop taking your current medications, but if you are on anti-coagulant drugs that cannot be temporarily stopped, you may not be eligible to participate.

Is the diagnostic test for Barrett's Esophagus safe?

Esophagogastroduodenoscopy (EGD), a procedure used to diagnose Barrett's Esophagus, is generally very safe with a low risk of serious complications like perforation or cardiopulmonary issues. However, there can be minor risks, especially in patients who are sick or sedated.12345

How is the EsoCheck/EsoGuard treatment different from other treatments for Barrett's Esophagus?

EsoCheck/EsoGuard is unique because it combines a non-invasive cell collection device (EsoCheck) with a DNA test (EsoGuard) to detect Barrett's Esophagus, offering a less invasive alternative to traditional endoscopy, which requires inserting a tube through the mouth to examine the esophagus.23678

What is the purpose of this trial?

The purpose of this study is to develop a method to detect Barrett's esophagus (BE) in individuals with a new office-based diagnostic test.

Research Team

Amitabh Chak | Digestive Health ...

Amitabh Chak, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for individuals over 50 with no chronic GERD, who have two risk factors for Barrett's Esophagus such as being white, having central obesity, male gender, smoking history or a family history of the condition. They must not have swallowing difficulties or blood clotting issues.

Inclusion Criteria

I am over 50 and have at least two risk factors for Barrett's esophagus.
I haven't had chronic heartburn or acid reflux for 5+ years.
I am over 50 and have at least two risk factors for Barrett's esophagus.
See 4 more

Exclusion Criteria

Inability to provide written informed consent
I don't have health issues that prevent me from undergoing specific esophageal exams or biopsies.
I have experienced heartburn or regurgitation weekly for over five years.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Testing

Participants complete a study questionnaire and undergo the EsoCheck/EsoGuard procedure to detect Barrett's esophagus

Up to 2 months
1 visit (in-person)

Endoscopy

Participants with positive EsoGuard results undergo standard of care upper endoscopy; selected negative participants may also undergo research EGD

Up to 2 months
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic procedures

4 weeks

Treatment Details

Interventions

  • EsoCheck/EsoGuard (EC/EG)
  • Esophago-gastro-duodenoscopy (EGD)
Trial Overview The study aims to test a new office-based diagnostic method called EsoCheck/EsoGuard (EC/EG) against the standard Esophago-gastro-duodenoscopy (EGD) procedure in detecting Barrett's Esophagus in patients without typical GERD symptoms.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: EC/EG & EGDExperimental Treatment2 Interventions
Participants will complete a study questionnaire about reflux symptoms. Performance of an EsoCheck (EC) procedure; the EC sample will subsequently be tested with the EsoGuard (EG) assay If EG assay results come back positive, participant is requested to complete standard of care (SOC) upper endoscopy (tissue samples collected) If EG assay results come back negative, selected participants (100 volunteers) will also undergo a research EGD if they consent

EsoCheck/EsoGuard (EC/EG) is already approved in United States for the following indications:

🇺🇸
Approved in United States as EsoCheck/EsoGuard for:
  • Detection of Barrett's Esophagus
  • Esophageal Precancer Screening

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials
472
Recruited
33,400+

Findings from Research

Esophagogastroduodenoscopy (EGD) is a very safe procedure with a low risk of serious complications, making it a reliable option for diagnosing and managing upper gastrointestinal diseases.
EGD is not only effective for diagnosis, especially when paired with biopsies, but it is also increasingly used for therapeutic purposes, potentially reducing the need for surgery.
The role of esophagogastroduodenoscopy in the diagnosis and management of upper gastrointestinal disorders.Cappell, MS., Friedel, D.[2019]
The study involving 50 patients indicates that using Lumevis™, which contains simethicone, N-acetylcysteine, and acetic acid, improves mucosal visualization during esophagogastroduodenoscopy (EGDS) without increasing examination time or complication rates.
The results suggest that this preparation method enhances lesion detection rates, making it a promising addition to routine EGDS procedures, although further prospective studies are needed to confirm these findings.
Lumevis ™: a new medical device to prepare patients for esophagogastroduodenoscopy. Experimental clinical study.Geraci, G., Palumbo, VD., Fazzotta, S., et al.[2021]
Adequate pre-endoscopy preparation and proper sedation, particularly with propofol, significantly enhance patient satisfaction and improve the detection of superficial gastrointestinal lesions during esophageo-gastro-duodenoscopy (EGD).
Innovations like image enhanced endoscopy and magnifying endoscopy have been shown to increase the diagnostic yield for conditions such as squamous cell carcinoma and early gastric cancer, indicating a trend towards more effective diagnostic techniques in EGD.
Recent advances in diagnostic upper endoscopy.Teh, JL., Shabbir, A., Yuen, S., et al.[2020]

References

The role of esophagogastroduodenoscopy in the diagnosis and management of upper gastrointestinal disorders. [2019]
Lumevis ™: a new medical device to prepare patients for esophagogastroduodenoscopy. Experimental clinical study. [2021]
Recent advances in diagnostic upper endoscopy. [2020]
A randomized trial of unsedated transnasal small-caliber esophagogastroduodenoscopy (EGD) versus peroral small-caliber EGD versus conventional EGD. [2022]
Electrocardiographic changes during oesophagogastroscopy. [2013]
Acceptability, Accuracy, and Safety of Disposable Transnasal Capsule Endoscopy for Barrett's Esophagus Screening. [2021]
Blinded comparison of esophageal capsule endoscopy versus conventional endoscopy for a diagnosis of Barrett's esophagus in patients with chronic gastroesophageal reflux. [2023]
Diagnostic inconsistencies in Barrett's esophagus. Department of Veterans Affairs Gastroesophageal Reflux Study Group. [2016]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security