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

NCT04301986 | Completed Results FDA Device

• 1 other identifier: 18-3290
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Barrett Esophagus; GERD

Outcome Measures

Primary Outcomes (1)

• 7 Days Post-EGD Impact of Events Score (IES)

  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 Outcomes (5)

• Visual Analog Scale (VAS) Score

  Day 1, Post-procedure (<24 hours of procedure completion)

• 7 Days Post-EGD Willingness to Repeat

  7 days post-EGD

• 7 Days Post-EGD Ranking of Preferred Screening Modality

  7 days post-EGD

• Number of Participants Reporting Preferred Screening Modality

  7 days post-EGD

• Factors Influencing the Preferred Screening Modality

  7 days post-EGD

Study Arms (2)

TNE Followed by EGD

EXPERIMENTAL

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); Device: Esophagogastroduodenoscopy

Cytosponge, then TNE, followed by EGD

EXPERIMENTAL

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; Device: Transnasal Endoscopy (TNE); Device: Esophagogastroduodenoscopy

Interventions

Cytosponge DEVICE

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 \[34° to 54°F\]).

Also known as: Cytosponge Cell Collection Device

Cytosponge, then TNE, followed by EGD

Transnasal Endoscopy (TNE) DEVICE

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.

Also known as: Olympus Neonatal (ultrathin) endoscope

Cytosponge, then TNE, followed by EGD; TNE Followed by EGD

Esophagogastroduodenoscopy DEVICE

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).

Also known as: EGD

Cytosponge, then TNE, followed by EGD; TNE Followed by EGD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• American Gastroenterological Association: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Barrett Esophagus; Gastroesophageal Reflux

Interventions

Endoscopes; Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Surgical Equipment; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Ariel E. Watts, Assistant Director of Clinical Trial Operations
• Organization: UNC Center for Esophageal Diseases & Swallowing

ariel_watts@med.unc.edu

919-962-7316

Study Officials

• Swathi Eluri, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 10, 2020
• Study Start: August 11, 2020
• Primary Completion: May 10, 2022
• Study Completion: May 10, 2022
• Last Updated: May 8, 2023
• Results First Posted: May 8, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)