Patient Acceptance and Preference Among Screening Modalities for Detection of Barrett's Esophagus
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04301986 |
Recruitment Status :
Recruiting
First Posted : March 10, 2020
Last Update Posted : September 8, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Barrett Esophagus GERD | Device: Cytosponge Device: Transnasal Endoscopy (TNE) Device: Esophagogastroduodenoscopy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Patient Acceptance and Preference Among Screening Modalities for Detection of Barrett's Esophagus |
Actual Study Start Date : | August 11, 2020 |
Estimated Primary Completion Date : | September 2022 |
Estimated Study Completion Date : | September 2022 |
Arm | Intervention/treatment |
---|---|
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 The scope will be withdrawn from the nares following completion of the exam.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 Name: 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 Name: 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: 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 Name: Cytosponge Cell Collection Device 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 Name: 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 Name: EGD |
- 7 days post-EGD Impact of Events Score (IES) - Cytosponge [ 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 Impact of Events Score (IES) - TNE [ 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 Impact of Events Score (IES) - EGD [ 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.
- Visual Analog Scale (VAS) Score - Cytosponge [ Time Frame: Day 1, Post-Cytosponge procedure ]Visual Analog Scale (VAS): 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."
- Visual Analog Scale (VAS) Score - TNE [ Time Frame: Day 1, Post-TNE procedure ]Visual Analog Scale (VAS): 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."
- Visual Analog Scale (VAS) Score - EGD [ Time Frame: Day 1, Post-EGD Procedure ]Visual Analog Scale (VAS): 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."
- 7 days post-EGD Willingness to repeat - Cytosponge [ Time Frame: 7 days post-EGD ]7 days post-EGD Willingness to repeat (Y/N) - Cytosponge
- 7 days post-EGD Willingness to repeat - TNE [ Time Frame: 7 days post-EGD ]7 days post-EGD Willingness to repeat (Y/N) - TNE
- 7 days post-EGD Willingness to repeat - EGD [ Time Frame: 7 days post-EGD ]7 days post-EGD Willingness to repeat (Y/N) - EGD
- 7 days post-EGD Ranking of preferred screening modality [ Time Frame: 7 days post-EGD ]Subjects will be asked to rank of 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.
- Number of participants reporting preferred screening modality [ Time Frame: 7 days post-EGD ]Participants will be asked what factors influenced preference in choosing preferred screening modality.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04301986
Contact: Ariel E Watts | 9198430821 | ariel_watts@med.unc.edu | |
Contact: Susie Moist | 919-966-7655 | susan_moist@med.unc.edu |
United States, North Carolina | |
University of North Carolina at Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
Contact: Ariel E Watts 919-843-0821 ariel_watts@med.unc.edu | |
Contact: Susie Moist 919-966-7655 susan_moist@med.unc.edu | |
Principal Investigator: Swathi Eluri, MD |
Principal Investigator: | Swathi Eluri, MD | University of North Carolina, Chapel Hill |
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT04301986 |
Other Study ID Numbers: |
18-3290 |
First Posted: | March 10, 2020 Key Record Dates |
Last Update Posted: | September 8, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Barrett Esophagus Precancerous Conditions Neoplasms |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |