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

NCT03167970 | Completed FDA Device

• 1 other identifier: PS0084
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of Treatment related adverse events of capsule endoscopy in comparison to standard esophagogastroduodenoscopy

  1 year

Study Arms (1)

Pill cam and EGD

Patients in this arm is requested to swallow the esophageal capsule and then undergo standard EGD.

Device: Pill cam; Other: EGD

Interventions

Pill cam DEVICE

Patient is asked to swallow the esophageal capsule.

Pill cam and EGD

EGD OTHER

Patient will undergo standard EGD

Pill cam and EGD

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Midwest Biomedical Research Foundation: lead
• Medtronic Spine LLC: collaborator

Study Sites (1)

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

Location

Related Publications (3)

• 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.

  PMID: 20032324 BACKGROUND

• 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.

  PMID: 16000923 BACKGROUND

• 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.

  PMID: 22134936 BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Complementary Therapies

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Prateek Sharma, MD

  Kansas City VA Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: May 30, 2017
• Study Start: May 3, 2017
• Primary Completion: December 6, 2017
• Study Completion: January 14, 2018
• Last Updated: January 19, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)