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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03685903
Recruitment Status : Enrolling by invitation
First Posted : September 26, 2018
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Patients Indicated for Periampullary or Pancreaticobiliary Examination Device: CapsoCam® Plus (SV-3) capsule endoscope Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Actual Study Start Date : September 26, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: CapsoCam® Plus (SV-3) capsule endoscope
Endoscope Capsule
Device: CapsoCam® Plus (SV-3) capsule endoscope
Endoscope Capsule




Primary Outcome Measures :
  1. The ability to detect and visualize the duodenal papilla [ Time Frame: during capsule endoscopy procedure ]
    Rate of duodenal papilla detection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685903


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Capso Vision, Inc.
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Responsible Party: Capso Vision, Inc.
ClinicalTrials.gov Identifier: NCT03685903    
Other Study ID Numbers: CLN-CVI-4801
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No