The primary objective of the study is to demonstrate safety and efficacy of the ALIMAXX-B* covered biliary stent.The secondary objective of the study is to evaluate technical success of stent placement, , re-interventions and time to occlusion.
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Primary endpoints of this trial will be as follows:
a. Absence of clinically significant stent occlusion or migration within 6
month follow-up or prior to death, whichever occurs first. Clinically
significant stent occlusion will be suggested by the development of symptoms
including pruritis and/or cholangitis. Signs suggesting clinically significant
occlusion include development of jaundice. Findings suggesting clinically
significant stent occlusion include a 30% increase in bilirubin from its lowest
point following stent placement. Migration of the stent by > 0.5 cm in
association with any of the above defined Symptoms, Signs or Findings will be
interpreted as clinically significant. These observations and/or additional
findings of cholestasis (elevation of ALP, AST and ALT) with or without imaging
defining ductal dilation may be interpreted to define clinically significant
stent occlusion
b. Device safety, including assessments of stent related complications and
overall complication rate comparable to clinical literature
Secondary outcome
The secundary outcomes of the studie are as follows:
a. Reduction in conjugated bilirubin >30% or return to normal range compared to
baseline value at 1 week post stent placement.
b. Independent review of cholangiographic and X-ray images confirming stent
patency and position
c. Assessment of stent position at all follow-up visits via X-ray
d. Assessment of biliary re-intervention; defined as any endoscopic,
percutaneous or surgical procedure to improve biliary drainage post stent
placement.
e. Assessment of patient survival post stent placement
f. Occurrence of unanticipated adverse device effects (UADE) or serious adverse
device effects (SADE)
Background summary
The majority of patients who have malignant biliary strictures cannot undergo
resection. Biliary stent placement is a well-established, palliative treatment
for patients with malignant biliary strictures. Plastic stents can effectively
palliate malignant biliary obstruction. However, a common complication of
plastic stents is late stent occlusion, therefore, necessitating stent
replacement.
The larger diameter self-expanding metal stents (SEMS) not only reduce stent
occlusion but also significantly increase stent patency.
This is a clinical evaluation of ALIMAXX-B*, a fully covered SEMS, which will
be conducted outside of the US. The ALIMAXX-B* used in this study is CE marked
and meets the regulatory requirements of the countries where clinical sites
reside.
Study objective
The primary objective of the study is to demonstrate safety and efficacy of the
ALIMAXX-B* covered biliary stent.
The secondary objective of the study is to evaluate technical success of stent
placement, , re-interventions and time to occlusion.
Study design
Prospective, multi-center, single arm, open-label, confirmatory study compared
to clinical literature.
Intervention
An ALIMAXX-B biliary stent will be placed during ERCP.
Study burden and risks
The study schedule exist of an enrollment visit and 3 follow up visits.
During the enrollment visit patients will be ask about their medical history
and their use of medication.
After that a blood sample will be taken to measure liver function tests
(comparable with standard treatment). Additional the stent will be placed
during ERCP.
After 1 week, 3 weeks and 6 months their will be a follow up visit. Patients
will be ask about their medication use and another blood sample will be taken
to measure liver function tests. After that a supine X-ray will be taken to
determine the position of the stent.
Patient will be followed for a maximum of 6 months.
9013 Perimeter Woods Dr.
Charlotte, NC 28216
USA
9013 Perimeter Woods Dr.
Charlotte, NC 28216
USA
Listed location countries
Age
Inclusion criteria
a. Malignant obstructive disease at the level of the extrahepatic CBD
b. Willing and able to comply with study procedures and provide written informed consent
c. > 18 years of age presenting with biliary obstruction
Exclusion criteria
a. Benign obstruction of the CBD
b. Malignancy involving intrahepatic ducts or duodenum
c. Stricture >8cm in length
d. Inability to pass a guidewire through the stricture area
e. Prior biliary stent
f. Perforation of any duct within the biliary tree
g. Life expectancy of <90 days
h. Disease that is amenable to curative resection
i. INR > 1.5
j. Prior gastric bypass or biliroth type I or type II gastric resection
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL23611.041.08 |