Evaluation of Performance Characteristics of Capsule Endoscopy With PillCam UGI Capsule Compared to Standard Endoscopy
Completed
Conditions studied: Barrett Esophagus
In brief
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.
Key facts
- Study ID
- NCT03167970
- Run by
- Midwest Biomedical Research
- People needed
- 21
- Starts
- 2017-05-03
- Expected to finish
- 2018-01-14
- Last updated by the study team
- 2018-01-19
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Kansas City VA Medical Center — Kansas City, Missouri, United States
Full record on ClinicalTrials.gov
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