Tethered Capsule Endoscope in Screening Patients With Barrett Esophagus
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|ClinicalTrials.gov Identifier: NCT02729948|
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Barrett Esophagus||Other: Survey Administration Device: Tethered Capsule Endoscope||Not Applicable|
I. Evaluate image quality and usability of the tethered capsule endoscope after repeated clinical use and reprocessing.
II. Evaluate safety issues associated with the use of the device for this subject population - was there any noticeable difference from prior study of subjects at high risk of Barrett's esophagus using the same device, but without reprocessing.
I. Study other specified device characteristics or device application considerations.
II. Obtain preliminary data for use in designing a subsequent pivotal study of the device.
Patients swallow the tethered capsule endoscope (TCE) and undergo endoscopic examination while they are seated on a standard endoscopy gurney. Patients undergo standard of care EGD on the same day.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Use of a Tethered Capsule Endoscope in Screening for Barrett's Esophagus|
|Actual Study Start Date :||July 28, 2016|
|Actual Primary Completion Date :||August 3, 2017|
|Actual Study Completion Date :||August 3, 2017|
Experimental: Screening (TCE)
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
Other Name: TCE
- Consistent image quality [ Time Frame: At the conclusion of TCE exam (day 1) ]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.
- 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 [ Time Frame: At the conclusion of TCE exam (day 1) ]
- Incidence of adverse events associated with TCE use [ Time Frame: Up to 1 year ]
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): NCT02729948
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Michael Saunders||Fred Hutch/University of Washington Cancer Consortium|