Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Archimedes Biodegradable Biliary and Pancreatic Stents (ARCHIMEDES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03767166
Recruitment Status : Completed
First Posted : December 6, 2018
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Brief Summary:

This is a prospective, phase II, single-centre, non-randomised, single-arm study, enrolling patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic plastic stent positioning during ERCP.

On procedure day, the study team will confirm that the patient meets all the inclusion criteria and none of the exclusion criteria.

The patient will undergo the ABS insertion and monitored and follow-up accordingly to biodegration variant.


Condition or disease Intervention/treatment
Pancreatic Diseases Device: Biodegradable biliary and pancreatic stents placement

Layout table for study information
Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Single Arm Study to Evaluate the Feasibility of the Archimedes Biodegradable Biliary and Pancreatic Stents Placement
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Biodegradable biliary and pancreatic stents placement
    Biodegradable biliary and pancreatic stents placement


Primary Outcome Measures :
  1. Biodegradation time [ Time Frame: 24 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic plastic stent positioning during ERCP.
Criteria

Inclusion Criteria:

  • Patients with an indication to position one ore more biliary plastic stents during ERCP
  • Patients with an indication to position a pancreatic plastic stent during ERCP

Exclusion Criteria:

  • Age < 18 y
  • Life expectancy < 1 m,
  • Inability to pass a guidewire through stricture
  • Contra-indication for endoscopy or interventional radiology
  • Presence of partial gastric resection
  • Unsigned informing consent form, ICF
  • Pregnancy
  • Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767166


Locations
Layout table for location information
Italy
Endoscopy Unit, Humanitas Research Hospital
Rozzano, Milano, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT03767166    
Other Study ID Numbers: 2275
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Diseases
Digestive System Diseases