NCT03685903

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

September 26, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

1.8 years

First QC Date

September 24, 2018

Last Update Submit

May 28, 2020

Conditions

Patients Indicated for Periampullary or Pancreaticobiliary Examination

Outcome Measures

Primary Outcomes (1)

  • The ability to detect and visualize the duodenal papilla

    Rate of duodenal papilla detection

    during capsule endoscopy procedure

Study Arms (1)

CapsoCam® Plus (SV-3) capsule endoscope

EXPERIMENTAL

Endoscope Capsule

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

Interventions

CapsoCam® Plus (SV-3) capsule endoscopeDEVICE

Endoscope Capsule

CapsoCam® Plus (SV-3) capsule endoscope

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with existing biliary stent will be excluded
  • Patient refusal to undergo procedure, unstable cardiopulmonary, neurologic, or cardiovascular status; existing bowel perforation
  • Structural abnormalities of esophagus, stomach, small intestine at the discretion of physician.
  • 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.
  • Any other contra-indicated condition as noted on the CapsoCam® Plus (SV-3) Instructions for Use, package insert.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Interventions

Capsule Endoscopes

Intervention Hierarchy (Ancestors)

Endoscopes, GastrointestinalEndoscopesDiagnostic EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 26, 2018

Study Start

September 26, 2018

Primary Completion

July 1, 2020

Study Completion

September 15, 2020

Last Updated

May 29, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)