Clinical trial · Observational
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
NCT03167970CI-TRIAL-00031287completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EGD | Other | — | UNRESOLVED |
| Pill cam | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pill cam and EGD
- description
- Patients in this arm is requested to swallow the esophageal capsule and then undergo standard EGD.
- interventionNames
- Device: Pill cam
- Other: EGD
Primary outcomes (1)
- measure
- The overall diagnostic accuracy of capsule endoscopy in predicting the presence and extent of Barrett's esophagus in comparison to standard esophagogastroduodenoscopy
- timeFrame
- 1 year
- description
- The ability to accurately predict the presence of Barrett's esophagus by capsule endoscopy and standard EGD will be measured.
Secondary outcomes (1)
- measure
- Incidence of Treatment related adverse events of capsule endoscopy in comparison to standard esophagogastroduodenoscopy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDSharma 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
- BACKGROUNDEliakim 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
- BACKGROUNDChang 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