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

May 4, 2023 updated by: University of North Carolina, Chapel Hill
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 international normalised ratio (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TNE Followed by EGD
Subjects will undergo administration of a 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.
Device: Transnasal Endoscopy (TNE)
In an upright position, the scope will be inserted via the nares to examine the posterior pharynx, esophagus and proximal stomach with the transnasal endoscopy approach. The scope will be withdrawn from the nares following completion of the exam.
Other Names:
  • Olympus Neonatal (ultrathin) endoscope
Device: Esophagogastroduodenoscopy
Laying on the subjects' left side, the flexible endoscope is inserted through the mouth to allow visualization of the esophageal mucosa from the upper esophageal sphincter all the way to the esophagogastric junction (EGJ).
Other Names:
  • EGD
Experimental: Cytosponge, then TNE, followed by EGD
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.
Device: Transnasal Endoscopy (TNE)
In an upright position, the scope will be inserted via the nares to examine the posterior pharynx, esophagus and proximal stomach with the transnasal endoscopy approach. The scope will be withdrawn from the nares following completion of the exam.
Other Names:
  • Olympus Neonatal (ultrathin) endoscope
Device: Esophagogastroduodenoscopy
Laying on the subjects' left side, the flexible endoscope is inserted through the mouth to allow visualization of the esophageal mucosa from the upper esophageal sphincter all the way to the esophagogastric junction (EGJ).
Other Names:
  • EGD
Device: Cytosponge
In a seated position, subjects will swallow the Cytosponge capsule with 150-250 mL of water. Seven minutes and 30 seconds to ten minutes after ingestion, the sponge is then withdrawn by gentle traction on the suture. After retrieval, the string is cut and the retrieved foam sphere containing the cytological specimen is immersed in fixative and stored refrigerated (1° to 12°C [34° to 54°F]).
Other Names:
  • Cytosponge Cell Collection Device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
7 Days Post-EGD Impact of Events Score (IES)
Time Frame: 7 days post-EGD
Impact of Events Score (IES): scale was developed to assess the distress associated with a specific life event. IES scores range from 0-75, with higher scores indicating more severe distress associated from an event. Scores ≥ 44 indicate a event has severe impact on self-reported distress while scores ≤ 25 indicate the event may have an effect on distress.
7 days post-EGD

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) Score
Time Frame: Day 1, Post-procedure (<24 hours of procedure completion)
Visual Analog Scale (VAS): 100-mm horizontal line on which the participant's pain intensity is represented by a point between the extremes of 0 reflecting "no pain at all" and 100 reflecting the "worst pain imaginable."
Day 1, Post-procedure (<24 hours of procedure completion)
7 Days Post-EGD Willingness to Repeat
Time Frame: 7 days post-EGD
7 days post-EGD participants were asked about their willingness to repeat the maneuvers (Yes/No).
7 days post-EGD
7 Days Post-EGD Ranking of Preferred Screening Modality
Time Frame: 7 days post-EGD
Participants asked to rank preferred screening modality in order (1,2,3). Scores range from 0-3. Scores of 1 indicate a preference, while scores of 3 indicate aversion.
7 days post-EGD
Number of Participants Reporting Preferred Screening Modality
Time Frame: 7 days post-EGD
Participants asked "Which procedure would you prefer to undergo again?" Only one item could be selected.
7 days post-EGD
Factors Influencing the Preferred Screening Modality
Time Frame: 7 days post-EGD
Participants asked what factors influenced preference in choosing preferred screening modality. Selection options were: discomfort/pain; time (preparation time and post-procedure); cost; and sedation. Participants could provide multiple response selections.
7 days post-EGD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Gastroenterological Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Swathi Eluri, MD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-3290

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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