N/A
Completed N=33
AXIOS Stent & Delivery System Study
Pancreatic Pseudocyst(s)
Source: ClinicalTrials.gov NCT01419769 ↗
Enrolled (actual)
33
Serious AEs
48.5%
Results posted
Nov 2014
Primary outcomePrimary: Safety - Freedom From Major Complications: Access Site-related Bleeding — 100 percentage of patients
Summary
The Xlumena AXIOS Stent and Delivery System is an investigational device in the USA, and this study is being conducted under an Investigational Device Exemption (IDE) granted by the US Food and Drug Administration (FDA).
The study design is prospective, multi-center, non-blinded, single-arm (nonrandomized) study. Up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
Patients will be followed at (approximately) 30 days and/or 60 days depending upon pseudocyst resolution confirmation, at 1-week post-stent removal,and possibly at 3 and 6 month post-stent removal.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety - Freedom From Major Complications: Access Site-related Bleeding |
100 | — |
| PRIMARY Safety - Freedom From Major Complications: Access Site-related Infection |
96.6 | — |
| PRIMARY Safety - Freedom From Major Complications: Perforation |
100 | — |
| PRIMARY Safety - Freedom From Major Complications: Stent Migration/Dislodement |
96.6 | — |
| PRIMARY Safety - Freedom From Major Complications: Tissue Injury |
100 | — |
| PRIMARY Safety - Freedom From Major Complications: SAE's |
84.8 | — |
| SECONDARY Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days |
93.1 | — |
| SECONDARY Effectiveness: Stent Removability at 30 Days and/or 60 Days |
96.7 | — |
| SECONDARY Effectiveness: Technical Success |
30; 29 | — |
| SECONDARY Clinical Success |
86.2 | — |
Eligibility Criteria
Inclusion Criteria
- (patients must meet all criteria)
- Age between 18 and 75 years old, male or female.
- Eligible for endoscopic intervention.
- Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage
- Symptomatic pancreatic pseudocyst having the following characteristics:
- Greater than or equal to 6 cm in size (based upon the maximum crosssectional area in the CT scan),
- Adherent to bowel wall, and
- ≥70% fluid content
- Patient understands the study requirements and the treatment procedures and provides written Informed Consent using a form that has been approved by the local Institutional Review Board or Ethics Committee before any study-specific tests or procedures are performed.
- Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.
Exclusion Criteria
- (patients meeting any of the below criteria will be excluded from study)
- 75 years of age
- Pancreatic pseudocysts having the following characteristics:
- Require nasocystic drainage,
- 1.5 and not correctable
- presence of a bleeding disorder
- platelets < 50,000/mm3
- Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis).
- Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound)
- Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient.
- Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.
- Currently participating in another investigational drug of device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
Data sourced from ClinicalTrials.gov (NCT01419769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.