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AXIOS Stent & Delivery System Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xlumena, Inc.
ClinicalTrials.gov Identifier:
NCT01419769
First received: August 15, 2011
Last updated: November 12, 2014
Last verified: November 2014

August 15, 2011
November 12, 2014
August 2011
June 2012   (final data collection date for primary outcome measure)
  • Safety - Freedom From Major Complications: Access Site-related Bleeding [ Time Frame: Through the duration of the 1-week post-stent removal study period ] [ Designated as safety issue: Yes ]
    Subjects are free of access site-related bleeding requiring transfusion
  • Safety - Freedom From Major Complications: Access Site-related Infection [ Time Frame: Through the duration of the 1-week post-stent removal study period ] [ Designated as safety issue: Yes ]
    Subjects are free of access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization
  • Safety - Freedom From Major Complications: Perforation [ Time Frame: Through the duration of the 1-week post-stent removal study period ] [ Designated as safety issue: Yes ]
    Subjects are free of surgery for access-site related perforation
  • Safety - Freedom From Major Complications: Stent Migration/Dislodement [ Time Frame: Through the duration of the 1-week post-stent removal study period ] [ Designated as safety issue: Yes ]
    Treated subjects are free of stent migration/ dislodgement into the pseudocyst or enteral lumen
  • Safety - Freedom From Major Complications: Tissue Injury [ Time Frame: Through the duration of the 1-week post-stent removal study period ] [ Designated as safety issue: Yes ]
    Subjects are free of tissue injury (ulceration to the submucosa) at stent site persisting through 1-week post-stent removal.
  • Safety - Freedom From Major Complications: SAE's [ Time Frame: Through the duration of the 1-week post-stent removal study period ] [ Designated as safety issue: Yes ]
    Treated subjects are free of serious adverse event classified as implant-associated or implant/endoscopic procedure-associated.
Safety - Freedom from major complications [ Time Frame: Through the duration of the 1-week post-stent removal study period ] [ Designated as safety issue: Yes ]
  • 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;
Complete list of historical versions of study NCT01419769 on ClinicalTrials.gov Archive Site
  • Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days [ Time Frame: Up to 60 days ] [ Designated as safety issue: No ]
    Stent lumen patency at 30 days and/or 60 days.
  • Effectiveness: Stent Removability at 30 Days and/or 60 Days [ Time Frame: Up to 60 days ] [ Designated as safety issue: No ]
    AXIOS stent removal was indicated at the time of pseudocyst resolution (≤ 3 cm diameter) or at 60 the day post procedure visit. Scheduled examination for pseudocyst resolution was designated at 30 days for removal if the pseudocyst resolution criterion was met. Otherwise, the stent was left in place for removal at the 60 day visit.
  • Effectiveness: Technical Success [ Time Frame: Up to 60 days ] [ Designated as safety issue: No ]
    Placement of the AXIOS Stent using the AXIOS Delivery System and removal of the AXIOS Stent using a standard endoscopic snare.
  • Clinical Success [ Time Frame: Up to 60 days ] [ Designated as safety issue: No ]
    Clinical success is defined as at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days.
Effectiveness [ Time Frame: @ 30 days and/or 60 days post-procedure follow-up ] [ Designated as safety issue: No ]
  • Stent lumen patency at 30 days and/or 60 days.
  • Stent removability at 30 days and/or 60 days.
  • Technical Success: Successful placement of the AXIOS stent using the AXIOS delivery system and successful removal of the AXIOS stent using a standard endoscopic snare.
  • Clinical Success: At least 50% decrease in pseudocyst size, based on radiographic analysis at 30 days and/or 60 days.
Not Provided
Not Provided
 
AXIOS Stent & Delivery System Study
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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Pseudocyst(s)
Device: AXIOS Stent & Delivery System

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.

Experimental: AXIOS Stent and Delivery System
Intervention: Device: AXIOS Stent & Delivery System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2013
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Spain
 
NCT01419769
CD00744
Yes
Xlumena, Inc.
Xlumena, Inc.
Not Provided
Not Provided
Xlumena, Inc.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP