Tethered Capsule Endoscope in Screening Patients With Barrett Esophagus

NCT02729948 | Completed DMC FDA Device

• 3 other identifiers: 9561NCI-2016-00112P30CA015704
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies how well tethered capsule endoscope works in screening patients with Barrett esophagus (BE), a condition where the lining of the esophagus has changed or has been replaced with abnormal cells that may lead to cancer also called esophageal cancer. In an attempt to prevent the progression from BE to esophageal cancer, patients undergo a standard procedure called esophagogastroduodenoscopy (EGD) where patients are sedated and the doctor uses an endoscope to examine the tissue in the esophagus. Tethered capsule endoscope is a tiny capsule with a laser scan inside and a very thin cord attached to it. Patients swallow the capsule and the thin cord keeps the capsule in specific area in the esophagus. After pictures of the lining of esophagus are taken, the capsule is removed using the thin cord. Tethered capsule endoscope may be able to identify tissue changes in patients with BE without the need for sedation or anesthesia, thus eliminating the associated risks and costs associated with EGD.

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (3)

• Consistent image quality

  Consistent image quality defined as no significant degradation of lateral spatial resolution \[line pairs per mm\] and axial depth of focus \[mm\], maximum field of view \[degrees cone angle\], and color fidelity \[qualitatively matches color chart\] when measured after use in the clinic using color and resolution test targets and a test chamber to measure field of view. The standard care EGD will be digitally recorded to allow for review and comparison to the TCE procedure by a blinded, expert endoscopist.

  At the conclusion of TCE exam (day 1)

• Consistent usability defined as no significant change to the tolerance rating given by the patient by survey, and ease of use by the physician by survey, and time for completing the examination

  At the conclusion of TCE exam (day 1)

• Incidence of adverse events associated with TCE use

  Up to 1 year

Study Arms (1)

Screening (TCE)

EXPERIMENTAL

Patients swallow the TCE and undergo endoscopic examination while they are seated on a standard endoscopy gurney. Patients undergo standard of care EGD on the same day.

Other: Survey Administration; Device: Tethered Capsule Endoscope

Interventions

Survey Administration OTHER

Ancillary studies

Screening (TCE)

Tethered Capsule Endoscope DEVICE

Undergo TCE

Also known as: TCE

Screening (TCE)

Eligibility Criteria

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

You may qualify if:

• Ability and willingness to provide written informed consent
• Scheduled for endoscopic screening and/or evaluation of Barrett's esophagus

You may not qualify if:

• Previous history of a swallowing disorder, such as scleroderma, achalasia, esophageal stricture or esophageal diverticulum
• Symptoms of dysphagia
• Suspicion or known history of gastrointestinal obstruction
• History of prior surgery on the oropharynx, neck, esophagus, or stomach
• Current diagnosis of cancer, unstable cardiovascular disease, end-stage liver or kidney disease, or other major medical illness
• Currently taking anticoagulant medications or clopidogrel
• Major physical disability which would prevent subject from transferring from a chair to a bed and sitting in an upright position
• Inability to abstain from taking anything by mouth for at least 6 hours
• Currently pregnant
• Expected to undergo magnetic resonance imaging (MRI) within two weeks following the study procedure

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Endoscopes

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Study Officials

• Michael Saunders

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 25, 2016
• First Posted: April 6, 2016
• Study Start: July 28, 2016
• Primary Completion: August 3, 2017
• Study Completion: August 3, 2017
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

US (1)