Skip to main content
Clinical Trials/NCT04009746
NCT04009746
Recruiting
Not Applicable

Italian Registry of ERCP With Spyglass

Istituto Clinico Humanitas1 site in 1 country150 target enrollmentJanuary 21, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Biliary Condition
Sponsor
Istituto Clinico Humanitas
Enrollment
150
Locations
1
Primary Endpoint
Data collection of characteristics of ERCP with Spyglass
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure used for the diagnosis and treatment of diseases of the biliary tract, pancreas and papilla of Vater. The ERCP allows an indirect vision of the ductal and pancreatic system by means of the endoductal injection of contrast medium and the evaluation of these by X-rays. Recently, cholangioscopy has been developed using the Spy Glass system, introduced on the market in 2007. This allows a direct visualization of the bile duct and pancreatic pathway through the introduction of an optical probe inside the ductal system. SpyGlass was developed to overcome the limitations of traditional cholangioscopy and allow optically guided therapies for the treatment of stenoses and calculations. This is the first cholangioscopy system performed by a single disposable operator (SOC), with two dedicated irrigation channels, an optical channel and a therapeutic channel with a diameter of 1.2 mm. Everything is placed inside a 10 Fr Spy Scope ™ access and delivery catheter (3.3 mm), which allows the tip to flex in 4 directions to facilitate maneuverability and directionality in small ducts.

The irrigation channels of the SOC system allow a fluid flow rate of four to five times higher than that which can be obtained through the operating channel of conventional systems. In bench simulations with loaded Spy Bite ™ biopsy forceps, the SOC system presented a success rate in obtaining access to sites of double interest compared to that of a conventional 2-way limited bending choledocoscope.

Some studies have confirmed the adequacy of the Spy Glass system in providing adequate samples for histological diagnosis and successfully facilitating the treatment of stones.

The new single-use Spy Glass digital display system was introduced in 2014 and no multi-center experience on the use of this device is described to date.

Registry
clinicaltrials.gov
Start Date
January 21, 2016
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Istituto Clinico Humanitas
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • With an age above or equal to 18,
  • From which informed consent has been obtained,
  • Subjected to ERCP carried out by expert operators,
  • Subject to ERCP with SpyGlass.
  • Patients who do not meet all of the listed inclusion criteria will be excluded from this study

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Data collection of characteristics of ERCP with Spyglass

Time Frame: 12 Months

Frequencies of complications and distribution of population undergoing ERCP

Study Sites (1)

Loading locations...

Similar Trials