Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure.
Status unconfirmed · Phase 1
Conditions studied: Patients Indicated for Periampullary or Pancreaticobiliary Examination
In brief
This observational Non-Significant Risk (NSR) Study will be used to assess the ability of CapsoCam® Plus (SV-3) capsule endoscope to detect the duodenal papilla and visualize pathology or abnormalities in the periampullary area and will prospectively compare the capsule endoscopy and EUS/ERCP pictorial images acquired in procedures conducted in a minimum of 20 and a maximum of 200 research patients.
Key facts
- Study ID
- NCT03685903
- Run by
- Capso Vision, Inc.
- People needed
- 200
- Starts
- 2018-09-26
- Expected to finish
- 2020-09-15
- Last updated by the study team
- 2020-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males or females at least 18 years of age.
- Provided written HIPAA Informed Consent in the IRB approved language.
- Patients indicated for periampullary or pancreaticobiliary examination, with prior cross-sectional imaging (CT/MRI/US/other) performed within past 6 months.
You may not qualify if…
- Patients with existing biliary stent will be excluded
- EUS/ERCP exclusion criteria: per medical practice, including:
- Patient refusal to undergo procedure, unstable cardiopulmonary, neurologic, or cardiovascular status; existing bowel perforation
- Structural abnormalities of esophagus, stomach, small intestine at the discretion of physician.
- Capsule Endoscopy (CE) exclusion criteria:
- CE exclusion criteria: difficulty swallowing, pregnancy, known motility issues (gastroparesis), known strictures, gastrointestinal obstructions, fistula or significantly distorted anatomy.
- Medical history of receipt of surgery, oncologic therapy, or radiation therapy who, in the opinion of the investigator, are at greater risk of capsule endoscope retention.
- Any other contra-indicated condition as noted on the CapsoCam® Plus (SV-3) Instructions for Use, package insert.
Where it is running
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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