Patient Acceptance and Preference Among Screening Modalities for Detection of Barrett's Esophagus

  • STATUS
    Recruiting
  • days left to enroll
    41
  • participants needed
    40
  • sponsor
    University of North Carolina, Chapel Hill
Updated on 18 September 2021
esophagogastroduodenoscopy
gastroesophageal reflux
endoscopy
reflux
barrett's esophagus
gastroscopy

Summary

To assess patient acceptance and preference among screening modalities, Esophagogastroduodenoscopy (EGD), Transnasal Esophagoscopy (TNE), and Cytosponge for Barrett's esophagus (BE). Subjects will undergo administration of Cytosponge and transnasal endoscopy (TNE) prior to their scheduled clinically indicated upper endoscopy performed per routine standard of care. Following the procedure, a follow-up phone call will be made during which an impact of events scale related to the subjective distress of each procedure, a preference and acceptance questionnaire, and adverse events related to study participation will be collected.

Description

Potential subjects will be identified via protocol and Institutional Review Board (IRB) methods prior to obtaining written informed consent. Once written informed consent is obtained and baseline demographic and medical history is collected, subjects will undergo administration of Cytosponge and transnasal endoscopy (TNE) prior to their scheduled clinically indicated upper endoscopy performed per routine standard of care. Following the procedure, a follow-up phone call will be made during which an impact of events scale related to the subjective distress of each procedure, a preference and acceptance questionnaire, and adverse events related to study participation will be collected.

Details
Condition gastric reflux, gerd, esophageal reflux, Precancerous condition, Precancerous Conditions, gastroesophageal reflux disease, Barrett's Esophagus, Gastroesophageal Reflux Disease (GERD), BARRETT'S ESOPHAGUS, Esophageal Disorders, gastro-oesophageal reflux, Esophageal Diseases, Gastroesophageal Reflux
Treatment esophagogastroduodenoscopy, Cytosponge, Transnasal Endoscopy (TNE)
Clinical Study IdentifierNCT04301986
SponsorUniversity of North Carolina, Chapel Hill
Last Modified on18 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with one of the following: Gastroesophageal Reflux Disease (GERD) OR Barrett's esophagus (BE)
At least 18 years of age at time of consent
Able and willing to provide written informed consent
Able and willing to comply with required study procedures and follow-up schedule
Presenting to UNC Hospitals for routine care upper endoscopy

Exclusion Criteria

History of pre-existing esophageal stenosis/ stricture, esophageal diverticulum or significant esophageal anatomic abnormalities (masses, obstructive lesions, etc.)
History of head and neck malignancy or anatomical abnormalities of the nasopharynx
Any history of Ear, Nose and Throat (ENT) surgery
History of significant epistaxis or hereditary hemorrhagic telangiectasia (HHT)
Sinus or pulmonary infection in the last 4 weeks
Current use of blood thinners such as coumadin, warfarin, clopidogrel, heparin and/or low molecular weight heparin (requires discontinuation of medication 7 days prior to and 7 days after esophagogastroduodenoscopy [EGD] and Cytosponge administration, aspirin use is OK)
Known bleeding disorder
Pregnancy, or planned pregnancy during the course of the study
Any history of esophageal varices, liver impairment of moderate or worse severity (Child's- Pugh class B & C) or evidence of varices noted on any past endoscopy
Any history of esophageal surgery, except for uncomplicated fundoplication
History of coagulopathy, with INR>1.3 and/or platelet count of <75,000
General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation
Subject has any condition that, in the opinion of the investigator or sponsor, would interfere with accurate interpretation of the study objectives or preclude participation in the trial
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note