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

NCT ID: NCT03685903

Last Updated: 2020-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-26

Study Completion Date

2020-09-15

Brief Summary

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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

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Conditions

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Patients Indicated for Periampullary or Pancreaticobiliary Examination

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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CapsoCam® Plus (SV-3) capsule endoscope

Endoscope Capsule

Group Type EXPERIMENTAL

CapsoCam® Plus (SV-3) capsule endoscope

Intervention Type DEVICE

Endoscope Capsule

Interventions

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CapsoCam® Plus (SV-3) capsule endoscope

Endoscope Capsule

Intervention Type DEVICE

Eligibility Criteria

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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

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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capso Vision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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CLN-CVI-4801

Identifier Type: -

Identifier Source: org_study_id

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