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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03685903

Enrollment

200

Registered

2018-09-26

Start date

2018-09-26

Completion date

2020-09-15

Last updated

2020-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Indicated for Periampullary or Pancreaticobiliary Examination

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.

Interventions

DEVICECapsoCam® Plus (SV-3) capsule endoscope

Endoscope Capsule

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026