Pancreatic Pseudocyst(s) Clinical Trial
Official title:
A Prospective, Multi-center, Non-blinded, Single-arm (Nonrandomized) Study of the AXIOS Stent and Delivery System
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.
OBJECTIVE:
To demonstrate the safety and effectiveness of the Xlumena AXIOS Stent and Delivery System
for endoscopic drainage of pancreatic pseudocysts in patients with symptomatic pancreatic
pseudocysts that are greater than or equal to 6 cm (≥6cm) in diameter, have ≥ 70% fluid
contents and are adherent to the bowel wall.
STUDY DESIGN:
Prospective, multi-center, non-blinded, single-arm (nonrandomized) study
KEY ENDPOINTS:
Safety: The safety endpoint is freedom from major complications through the duration of the
1-week post-stent removal study period, defined as:
1. Access site-related bleeding requiring transfusion;
2. Access site-related infection requiring intravenous or intramuscular antibiotics and/or
extended hospitalization;
3. Surgery for access-site related perforation;
4. Stent migration/dislodgement into the pseudocyst or enteral lumen;
5. Tissue injury, defined as ulceration to the submucosa at site of stent implant as
observed to persist through 1-week post-stent removal.
6. Serious adverse event classified as implant-associated or implant/endoscopic
procedure-associated;
Effectiveness:
1. Stent lumen patency at 30 days and/or 60 days
2. Stent removability at 30 days and/ or 60 days.
3. Technical success, defined as: placement of the AXIOS stent using the AXIOS delivery
system and removal of the AXIOS stent using a standard endoscopic snare.
4. Clinical success, defined as: at least a 50% decrease in pseudocyst size, based on
radiographic analysis, at 30 days and/or 60 days.
PATIENT POPULATION:
Patients between 18 and 75 years of age, suitable for transluminal drainage of symptomatic
pancreatic pseudocysts that are greater than or equal to 6 cm in diameter and adherent to
the bowel wall are candidates for study treatment.
FOLLOW-UP SCHEDULE:
Clinical follow-up evaluations of study endpoints will be conducted at 30 days and/or 60
days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
PLANNED NUMBER OF PATIENTS, SITES & REGIONS:
The target enrollment for the study is 24 subjects. Study will be conducted at up to 10
investigational sites in the United States, Japan and/or the European Community. A majority
of the patients will be enrolled in the United States.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02146352 -
AXIOS Stent With Electrocautery Enhanced Delivery System
|
N/A |