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

Patients Indicated for Periampullary or Pancreaticobiliary Examination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03685903
• Other study ID #: CLN-CVI-4801
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: September 26, 2018
• Est. completion date: September 15, 2020

Study information

• Verified date: May 2020
• Source: Capso Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: September 15, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Patients Indicated for Periampullary or Pancreaticobiliary Examination

Intervention

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

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Capso Vision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ability to detect and visualize the duodenal papilla	Rate of duodenal papilla detection	during capsule endoscopy procedure