- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03977779
Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis (ARCHIMEDE)
March 8, 2022 updated by: Institut Paoli-Calmettes
Prospective Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis
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.
Study Overview
Status
Recruiting
Study Type
Interventional
Enrollment (Anticipated)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marc Giovannini, MD
- Email: giovanninim@ipc.unicancer.fr
Study Locations
-
-
Provence-Alpes-Côte d'Azur
-
Marseille, Provence-Alpes-Côte d'Azur, France, 13009
- Recruiting
- Institut Paoli Calmettes
-
Contact:
- GOUARNE Caroline, PhD
- Phone Number: + 33 4 91 22 37 78
- Email: drci.up@ipc.unicancer.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age>18 years
- Patients at risk of developing a Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis (procedure and/or patient-related risk factors
Exclusion Criteria:
- Pregnant or breastfeeding women
- Recent diagnosis (<1 month) of acute pancreatitis
- contraindication to endoscopy
- Hypersensitivity to indomethacine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prophylactic biodegradable pancreatic stent placement
|
The ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients with a complete clearance of the biodegradable stent
Time Frame: Day 15
|
The degradation of the stent will be evaluated both duodenoscopy/fluoroscopy and endoscopy 15 days after its placement
|
Day 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2022
Primary Completion (Anticipated)
July 20, 2022
Study Completion (Anticipated)
September 5, 2022
Study Registration Dates
First Submitted
June 5, 2019
First Submitted That Met QC Criteria
June 5, 2019
First Posted (Actual)
June 6, 2019
Study Record Updates
Last Update Posted (Actual)
March 9, 2022
Last Update Submitted That Met QC Criteria
March 8, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARCHIMEDE-PANCREAS-IPC
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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