Status:

COMPLETED

International Study to Evaluate Outcomes and Safety of Patients Undergoing ERCP Using a Single-use Cholangioscope and Single-use Duodenoscope

Lead Sponsor:

Istituto Clinico Humanitas

Conditions:

Biliary Condition

Eligibility:

All Genders

18+ years

Brief Summary

Since its introduction more than 40 years ago, endoscopic retrograde cholangiopancreatography (ERCP) has fundamentally changed the treatment of biliopancreatic diseases. Since late 1970s there have be...

Eligibility Criteria

Inclusion

  • \- patients that required an ERCP with cholangioscopy performed with the single-use EXALT duodenoscope in combination with the Spyglass DS II

Exclusion

  • Age \< 18
  • Lack of follow-up data (30 days at least)
  • Less than 3 cases performed during the study period

Key Trial Info

Start Date :

January 27 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 31 2021

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT04712253

Start Date

January 27 2021

End Date

July 31 2021

Last Update

September 21 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, Italy, 20089