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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
Results First Received: November 12, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pancreatic Pseudocyst(s)
Intervention: Device: AXIOS Stent & Delivery System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
AXIOS Stent and Delivery System

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.


Participant Flow:   Overall Study
    AXIOS Stent and Delivery System  
STARTED     33  
COMPLETED     29  
NOT COMPLETED     4  
Did not receive the AXIOS stent                 3  
Not evaluable due to pigtail stents                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
AXIOS Stent and Delivery System

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.


Baseline Measures
    AXIOS Stent and Delivery System  
Number of Participants  
[units: participants]
  33  
Age  
[units: Years]
Mean ± Standard Deviation
  52.6  ± 14.0  
Gender  
[units: participants]
 
Female     15  
Male     18  
Region of Enrollment  
[units: participants]
 
United States     30  
Spain     3  
Height  
[units: inches]
Mean ± Standard Deviation
  67.4  ± 3.9  
Weight  
[units: pounds]
Mean ± Standard Deviation
  169.5  ± 43.5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Safety - Freedom From Major Complications: Access Site-related Bleeding   [ Time Frame: Through the duration of the 1-week post-stent removal study period ]

2.  Primary:   Safety - Freedom From Major Complications: Access Site-related Infection   [ Time Frame: Through the duration of the 1-week post-stent removal study period ]

3.  Primary:   Safety - Freedom From Major Complications: Perforation   [ Time Frame: Through the duration of the 1-week post-stent removal study period ]

4.  Primary:   Safety - Freedom From Major Complications: Stent Migration/Dislodement   [ Time Frame: Through the duration of the 1-week post-stent removal study period ]

5.  Primary:   Safety - Freedom From Major Complications: Tissue Injury   [ Time Frame: Through the duration of the 1-week post-stent removal study period ]

6.  Primary:   Safety - Freedom From Major Complications: SAE's   [ Time Frame: Through the duration of the 1-week post-stent removal study period ]

7.  Secondary:   Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days   [ Time Frame: Up to 60 days ]

8.  Secondary:   Effectiveness: Stent Removability at 30 Days and/or 60 Days   [ Time Frame: Up to 60 days ]

9.  Secondary:   Effectiveness: Technical Success   [ Time Frame: Up to 60 days ]

10.  Secondary:   Clinical Success   [ Time Frame: Up to 60 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Nancy Lockhorn
Organization: Xlumena, Inc.
phone: 650-961-9900 ext 252
e-mail: nlockhorn@xlumena.com


No publications provided


Responsible Party: Xlumena, Inc.
ClinicalTrials.gov Identifier: NCT01419769     History of Changes
Other Study ID Numbers: CD00744
Study First Received: August 15, 2011
Results First Received: November 12, 2014
Last Updated: November 12, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board