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Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis

Study acronym: ARCHIMEDE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 24, 2024 (before its estimated December 1, 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jul 20, 2022 to Dec 1, 2024
    • Study completion date: Sep 5, 2022 to Dec 15, 2024
    v5
  2. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Start date changed from estimate of Jul 2021 to Jan 20, 2022
    • Study sites: 0 to 1
    • Primary completion date: Feb 2022 to Jul 20, 2022
    • Study completion date: Mar 2022 to Sep 5, 2022
  3. Primary completion date: Nov 10, 2020 to Feb 2022
    • Start date: Apr 10, 2020 to Jul 2021
    • Study completion date: Nov 10, 2020 to Mar 2022
    v3
  4. Phase: Phase 2 to Not applicable
    • Start date: Dec 10, 2019 to Apr 10, 2020
    • Primary and study completion dates: May 10, 2021 to Nov 10, 2020
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The use of an endoprothesis in a pancreatic duct is a measure to minimize the incidence and severity of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis. In this study we will evaluate the use of a Biodegradable Endoprothesis: Archimede Fast Biodegradable Pancreatic Stent in patients with high risk of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis.The ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography. The efficacy and the security of the device will be evaluated.
Trial Details
NCT Number NCT03977779
Lead Sponsor Institut Paoli-Calmettes
Conditions
(from sponsor)		 Obstructive Jaundice, Biliary Stricture, Sphincter of Oddi Dysfunction
Related terms Jaundice, Obstructive, Sphincter of Oddi Dysfunction
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov