Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 187 participants, all of whom received a device called the WallFlex Biliary RX Fully Covered (FC) Stent System — a type of tube placed in the bile duct to help keep it open. Of the 187 people who started the trial, 177 completed it, and 10 did not complete it (the reasons were not detailed in the reported data). The trial was a single-group study, meaning everyone received the same device with no comparison group. The main thing the trial set out to measure was called "stent removability" — specifically, whether the stent could be removed using an internal camera procedure (endoscopy) without serious problems related to the removal, tracked from the time of removal up to one month afterwards. The reported data shows that out of the 187 participants who started, 132 participants had their stent removal recorded as meeting this definition. No further breakdown of the outcome — such as what happened in the remaining cases or why the numbers differ — was included in the data reported to ClinicalTrials.gov. There were no secondary outcome measure results included in the submitted data. It is worth noting that this was a single-arm trial (everyone received the same treatment), so the reported numbers describe what was observed in this one group only, with no direct comparison to another treatment or device. The reported data shows only what was measured and counted in this specific study population. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 24801350) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Pancreatitis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are 18 years of age or older
- You are willing and able to follow the study procedures and sign a consent form to take part
- You have been diagnosed with chronic pancreatitis, have had a liver transplant in the past, or have had another abdominal surgery before (including gallbladder removal)
- You need an ERCP procedure with a stent placed for one of these reasons: a bile duct blockage causing symptoms (such as jaundice, persistent bile buildup, or a bile duct infection) confirmed by imaging; a bile duct narrowing confirmed by imaging; or replacing a previous plastic stent used to treat a non-cancerous narrowing
Who may not be able to join:
- The narrowed area in the duct cannot be opened wide enough to fit the delivery device through
- The duct has a hole or tear in it
- The ducts inside the liver are too small for the stent
- Endoscopic procedures (procedures using a camera passed through the mouth) are not medically suitable for you
- The bile duct narrowing is caused by cancer
- The bile duct narrowing has a non-cancerous cause other than chronic pancreatitis, liver transplant, or previous abdominal surgery
- The narrowing is located less than 2 cm from where the bile duct splits into two branches
- You have a blocked or narrowed duodenum (the first part of the small intestine) causing your stomach to empty slowly
- You have previously had a self-expanding metal stent placed in your bile duct
- Imaging or endoscopy suggests the narrowing may be caused by reduced blood supply to the bile duct (confirm with trial site)
- You have a known connection or opening between your bile duct and another structure (bile duct fistula)
- You have a known allergy or sensitivity to any materials used in the stent or delivery device
- You have taken part in another clinical research study within the 90 days before signing consent, or are currently in another study
- (For chronic pancreatitis patients only) Your bile duct symptoms are related to a current episode of acute pancreatitis
- (For patients who have had abdominal surgery only) You have previously had part of your liver removed, or you have had a liver transplant
- (For liver transplant patients only) Your transplant came from a living donor
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Stent Removability
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.