Actively Recruiting
Evaluation of a Biodegradable Endoprothesis to Prevent Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Led by Institut Paoli-Calmettes · Updated on 2024-10-24
46
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of a biodegradable endoprothesis called the ARCHIMEDES Fast Biodegradable Pancreatic Stent in patients at high risk of developing Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis. The study focuses on assessing the effectiveness and safety of this device in reducing the incidence and severity of this condition. During the procedure known as Endoscopic Retrograde CholoangioPancreatography, the ARCHIMEDES stent will be placed in the pancreatic duct. This device is designed to biodegrade over time, and the study will monitor how well it works and how safe it is for patients. Participants will be evaluated for the complete clearance of the biodegradable stent by Day 15 after placement. The study involves monitoring patients closely after the procedure to assess outcomes related to the stent's performance and any potential complications. The total duration of participation revolves around this 15-day post-procedure period.
CONDITIONS
Brief Title
Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Patients at risk of developing Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis based on procedure or patient factors
You will not qualify if you...
- Pregnant or breastfeeding women
- Diagnosis of acute pancreatitis within the last month
- Contraindication to endoscopy
- Known allergy to indomethacine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure with follow-up until stent clearance
Participants receive placement of the ARCHIMEDES Fast biodegradable pancreatic stent during the Endoscopic Retrograde Cholangiopancreatography procedure.
1 procedure visit and follow-up assessments up to Day 15
Trial Site Locations
Total: 1 location
1
Institut Paoli Calmettes
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13009
Actively Recruiting
Research Team
D
Dominique Genre, MD
M
Marc Giovannini, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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