AXIOS Stent & Delivery System Study
Condition: Pancreatic Pseudocyst(s)
MeSH terms: Pancreatic Pseudocyst
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): AXIOS Stent & Delivery System
Intervention type(s): Device
Intervention description(s): The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at 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 between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: symptomatic pancreatic pseudocyst; pancreatic pseudocyst; transluminal drainage; minimally invasive; Nitinol stent; transmural endoscopic drainage; catheter based