Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure.

Capso Vision

Status and phase

Unknown

Phase 1

Conditions

Patients Indicated for Periampullary or Pancreaticobiliary Examination

Treatments

Device: CapsoCam® Plus (SV-3) capsule endoscope

Study type

Interventional

Funder types

Industry

Identifiers

NCT03685903

CLN-CVI-4801

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.