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

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.

Study Overview

• Status: Completed
• Conditions: Barrett Esophagus
• Intervention / Treatment: Device: Pill cam; Other: EGD

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.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • Kansas City VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Patients age: ≥ 18 years
• Patients with BE length ≥ 1cm undergoing upper endoscopy
• Willingness to undergo both unsedated, capsule endoscopy and conventional EGD
• Ability to provide written, informed consent and understand the responsibilities of trial participation

Exclusion Criteria:

• Coagulopathy with INR > 1.5, thrombocytopenia with platelet counts < 50,000
• Pregnant or planning a pregnancy during the study period
• Dysphagia
• Known esophageal diverticulum or stricture
• Swallowing disorder
• Known luminal, gastrointestinal stricture
• History of esophageal, gastric surgery
• Esophageal or GI motility disorder
• Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
• Known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
• Subjects with cardiac pacemakers or other implanted electromedical devices.
• Anticipated magnetic resonance imaging within 1 week of capsule ingestion

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pill cam and EGD; Patients in this arm is requested to swallow the esophageal capsule and then undergo standard EGD.	Device: Pill cam; Patient is asked to swallow the esophageal capsule.; Other: EGD; Patient will undergo standard EGD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The overall diagnostic accuracy of capsule endoscopy in predicting the presence and extent of Barrett's esophagus in comparison to standard esophagogastroduodenoscopy	The ability to accurately predict the presence of Barrett's esophagus by capsule endoscopy and standard EGD will be measured.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment related adverse events of capsule endoscopy in comparison to standard esophagogastroduodenoscopy	Wireless capsule endoscopy is generally considered safe. Potential risks resulting from capsule endoscopy are reported low and may include discomfort while swallowing, accidental aspiration and capsule retention leading to small bowel obstruction and perforation. the investigator will measure tolerability of capsule endoscopy as well as standard endoscopy using visual analogue scale.	1 year

Collaborators and Investigators

• Sponsor: Midwest Biomedical Research Foundation
• Collaborators: Medtronic Spine LLC

Publications and helpful links

General Publications

• Sharma P. Clinical practice. Barrett's esophagus. N Engl J Med. 2009 Dec 24;361(26):2548-56. doi: 10.1056/NEJMcp0902173. No abstract available. Erratum In: N Engl J Med. 2010 Apr 15;362(15):1450.
• Eliakim R, Sharma VK, Yassin K, Adler SN, Jacob H, Cave DR, Sachdev R, Mitty RD, Hartmann D, Schilling D, Riemann JF, Bar-Meir S, Bardan E, Fennerty B, Eisen G, Faigel D, Lewis BS, Fleischer DE. A prospective study of the diagnostic accuracy of PillCam ESO esophageal capsule endoscopy versus conventional upper endoscopy in patients with chronic gastroesophageal reflux diseases. J Clin Gastroenterol. 2005 Aug;39(7):572-8. doi: 10.1097/01.mcg.0000170764.29202.24.
• Chang JY, Talley NJ, Locke GR 3rd, Katzka DA, Schleck CD, Zinsmeister AR, Dunagan KT, Wu TT, Wang KK, Prasad GA. Population screening for barrett esophagus: a prospective randomized pilot study. Mayo Clin Proc. 2011 Dec;86(12):1174-80. doi: 10.4065/mcp.2011.0396.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2017
• Primary Completion (ACTUAL): December 6, 2017
• Study Completion (ACTUAL): January 14, 2018

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (ACTUAL): May 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 19, 2018
• Last Update Submitted That Met QC Criteria: January 17, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: PS0084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a funded study. A copy of de-identified data set will be provided to the sponsor in the form of case report forms (CRF) at the end of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes