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A Prospective, Multi-center, Non-blinded, Single-arm (Nonrandomized) Study of the AXIOS Stent and Delivery System


N/A
18 Years
75 Years
Not Enrolling
Both
Pancreatic Pseudocyst(s)

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Trial Information

A Prospective, Multi-center, Non-blinded, Single-arm (Nonrandomized) Study of the AXIOS Stent and Delivery System


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.


Inclusion Criteria:



- (patients must meet all criteria)

1. Age between 18 and 75 years old, male or female.

2. Eligible for endoscopic intervention.

3. Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage

4. 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

5. 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.

6. 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)

1. <18 or >75 years of age

2. Pancreatic pseudocysts having the following characteristics:

- Require nasocystic drainage,

- < 69% fluid content

3. The fluid collection to be drained is an immature pseudocyst

4. The fluid collection to be drained is a cystic neoplasm

5. The fluid collection to be drained is a pseudoaneurysm

6. The fluid collection to be drained is a duplication cyst

7. The fluid collection to be drained is a non-inflammatory fluid collection

8. There is more than one pseudocyst requiring drainage

9. Abnormal coagulation:

- INR > 1.5 and not correctable

- presence of a bleeding disorder

- platelets < 50,000/mm3

10. Altered anatomy that precludes the physician's ability to deliver the stent
(decision on a case by case basis).

11. Intervening gastric varices or vessels within a one centimeter radius of the
needle (visible using endoscopy or endoscopic ultrasound)

12. Any prior true anaphylactic reaction to contrast agents, nitinol (nickel
titanium), silicone or any other materials contacting the patient.

13. Female of childbearing potential with a positive pregnancy test prior to the
procedure or intends to become pregnant during the study.

14. 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety - Freedom from major complications

Outcome Description:

Absence of access site-related bleeding requiring transfusion Absence of access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization Absence of tissue injury, defined as ulceration to the submucosa at the site of stent implant. No surgery for access-site related perforation required No stent migration/dislodgement into the pseudocyst or enteral lumen. No serious adverse event classified as implant-associated or implant/surgical procedure-associated;

Outcome Time Frame:

Through the duration of the 1-week post-stent removal study period

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

CD00744

NCT ID:

NCT01419769

Start Date:

August 2011

Completion Date:

Related Keywords:

  • Pancreatic Pseudocyst(s)
  • symptomatic pancreatic pseudocyst
  • pancreatic pseudocyst
  • transluminal drainage
  • minimally invasive
  • Nitinol stent
  • transmural endoscopic drainage
  • catheter based
  • Pancreatic Pseudocyst

Name

Location

Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
Cornell UniversityNew York, New York  10021
Borland-Groover ClinicJacksonville, Florida  32256
California Pacific Medical Center (CPMC)San Francisco, California  94115
Unversity of Colorado DenverAurora, Colorado  80045
University of Chicago Medical Center (UCMC)Chicago, Illinois  60637