NCT03167970

Evaluation of Performance Characteristics of Capsule Endoscopy With PillCam UGI Capsule Compared to Standard Endoscopy

Evaluation of Performance Characteristics of Capsule Endoscopy With PillCam UGI Capsule Compared to Standard Endoscopy for Screening of Barrett's Esophagus: A Prospective Tandem Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: Midwest Biomedical Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is to examine the benefits of newly designed capsule with enhanced frame rate and wide angle compared to standard endoscopy, which may help enhance detecting esophageal diseases that otherwise may have been out of vision in the standard endoscopy, ultimately decreasing healthcare costs.

Detailed description

This is a pilot, single center, prospective, tandem study. All veteran patients with Barrett's esophagus scheduled for an upper EGD at Veterans Affairs Medical Center (Kansas City, MO, USA) for check-up of BE will be asked to swallow the pillcam prior to an EGD. A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study Eligible subjects at the participating institution who meet the inclusion criteria for this study will be offered the opportunity to participate in this clinical trial. To ensure that subjects are approached for potential study participation without bias, a Subject Screening Log will be maintained. This Log will track the basic demographic information of each subject approached for clinical trial inclusion and the resulting reason for exclusion from the clinical study if applicable. The duration of the study is expected to be approximately 12 months. Enrollment of Study patients will cease when approximately 20 patients have been enrolled.

Conditions

• Barrett Esophagus

Interventions

Type	Name	Description
DEVICE	Pill cam	Patient is asked to swallow the esophageal capsule.
OTHER	EGD	Patient will undergo standard EGD

Timeline

• Start date: 2017-05-03
• Primary completion: 2017-12-06
• Completion: 2018-01-14
• First posted: 2017-05-30
• Last updated: 2018-01-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study