Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure.
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/3/2019 |
| Start Date: | September 26, 2018 |
| End Date: | September 15, 2019 |
Prospective Observational Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure in Pancreaticobiliary and Periampullary Pathology
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with existing biliary stent will be excluded
- EUS/ERCP exclusion criteria: per medical practice, including:
1. Patient refusal to undergo procedure, unstable cardiopulmonary, neurologic, or
cardiovascular status; existing bowel perforation
2. Structural abnormalities of esophagus, stomach, small intestine at the discretion
of physician.
- Capsule Endoscopy (CE) exclusion criteria:
1. CE exclusion criteria: difficulty swallowing, pregnancy, known motility issues
(gastroparesis), known strictures, gastrointestinal obstructions, fistula or
significantly distorted anatomy.
2. 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.
3. Any other contra-indicated condition as noted on the CapsoCam® Plus (SV-3)
Instructions for Use, package insert.
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