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

Phase 1

• Conditions: Patients Indicated for Periampullary or Pancreaticobiliary Examination
• Interventions: Device: CapsoCam® Plus (SV-3) capsule endoscope

• Registration Number: NCT03685903
• Lead Sponsor: Capso Vision, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-24
• Study Start: 2018-09-26
• Study First Posted: 2018-09-26
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-05-29
• Primary Completion: 2020-07-01
• Study Completion: 2020-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CapsoCam® Plus (SV-3) capsule endoscope	CapsoCam® Plus (SV-3) capsule endoscope	Endoscope Capsule

Primary Outcome Measures

Name	Time	Method
The ability to detect and visualize the duodenal papilla	during capsule endoscopy procedure	Rate of duodenal papilla detection

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States