OCT Pilot in Esophagus

NCT03434834 | Completed Results FDA Device

• 2 other identifiers: Pro00090173R01CA210544
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to test a newly developed optical coherence tomography (OCT) device to determine 1) whether adequate tissue contact can be attained to acquire high quality images, and 2) to identify if these images can discern whether the imaged tissue is squamous or Barrett's Esophagus (BE) epithelium.

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (2)

• Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa

  Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.

  at baseline

• Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa

  Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy.

  at baseline

Secondary Outcomes (1)

• Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image

  at baseline

Study Arms (1)

OCT of esophagus

EXPERIMENTAL

optical coherence tomography of esophagus

Device: optical coherence tomography

Interventions

optical coherence tomography DEVICE

OCT measurements of 5 locations in the esophagus

OCT of esophagus

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting to University of North Carolina (UNC) for routine care upper endoscopy
• Meet one of the following criteria:
• Presenting to UNC for upper endoscopy of GI conditions without esophageal symptomology for with no history of gastroesophageal reflux disease (GERD) or other esophageal condition affecting the epithelium (asymptomatic controls), OR,
• History of dysplastic or non-dysplastic Barrett's Esophagus with prague criteria C1+ or M3+
• Aged 18 to 80
• Able to read, comprehend, and understand the informed consent document.

You may not qualify if:

• Prior esophageal surgery (uncomplicated nissen fundoplication OK)
• Pregnant women
• Unable to provide written informed consent

Sponsors & Collaborators

• Duke University: lead
• University of North Carolina, Chapel Hill: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Results Point of Contact

• Title: Dr. Adam Wax
• Organization: Duke University

a.wax@duke.edu

919-660-5143

Study Officials

• Adam Wax, Ph.D.

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 15, 2018
• Study Start: September 25, 2018
• Primary Completion: February 25, 2020
• Study Completion: March 25, 2020
• Last Updated: April 6, 2021
• Results First Posted: April 6, 2021

Record last verified: 2021-03

Locations

US (1)