Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS

NCT02524418 | Completed Results

• 1 other identifier: 483-2006
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective evaluation of the clinical utility of the new cholangioscopy platform SpyGlass DS. The aims of this study are to prospectively document the clinical utility and technical aspects of ERCP with cholangioscopy and/or pancreatoscopy in the diagnosis and management of pancreatic-biliary disorders.

Conditions

Biliary Tract Disease

Keywords

Main Pancreatic Duct

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Procedure Technical Success

  The performance of the Spyglass DS during the endoscopy will be based on the ability to reach the target site, obtain samples, and to deliver therapeutic intervention.

  Day 1

Secondary Outcomes (8)

• Time to Set-up the Spyglass DS for the Procedure

  approximately 2 hours

• Measurement of Total Procedure Time Using the Spyglass DS

  approximately 2 hours

• Measurement in Minutes for Spyglass DS Diagnostic Maneuvers

  approximately 2 hours

• Measurement in Minutes for Spyglass DS Therapeutic Maneuvers

  approximately 2 hours

• Number of Cholangioscopic Exams That Detected Ductal Stones

  Day 1

Study Arms (1)

Cholangiopancreatoscopy

OTHER

A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.

Procedure: Cholangiopancreatoscopy

Interventions

Cholangiopancreatoscopy PROCEDURE

An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.

Also known as: ERCP

Cholangiopancreatoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who have been scheduled to undergo a cholangiopancreatoscopy as routine clinical care

You may not qualify if:

• failure to provide informed consent
• any contraindications to endoscopy

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Shands at the University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Biliary Tract Diseases

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Dr. Peter V. Draganov MD
• Organization: University of Florida

peter.draganov@medicine.ufl.edu

352-273-9472

Study Officials

• Peter V Draganov, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 14, 2015
• Study Start: August 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 30, 2017
• Results First Posted: March 30, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)