Clinical trialNACompleted
AXIOS Stent With Electrocautery Enhanced Delivery System
- Outcome
- Outcome unknown
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- June 2014
- Expected end
- March 2015
- Enrollment
- 30 participants
- Sites
- 8
- Primary outcomes
- Safety/Adverse Event Outcome Measure 1; Safety/Adverse Event Outcome Measure 2; Safety/Adverse Event Outcome Measure 3; Safety/Adverse Event Outcome 4; Safety/Adverse Event Outcome Measure 5
- Sponsor
- Industry
- Results posted
- 2015-10-02
- Last update
- 2 October 2015
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Brief summary public domain (ClinicalTrials.gov)
The purpose of this study is to demonstrate the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for endoscopic transenteric drainage of pancreatic pseudocysts.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Safety/Adverse Event Outcome Measure 1 [Index procedure through 1-week post-stent removal]. Number, percentage of patients. Treatment (n=30): 100.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Stent Retention Outcome Measure [30 or 60 days post-procedure]. Number, percentage of patients. Treatment (n=30): 100.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Lumen Patency Outcome Measure [30 and/or 60 days post-procedure]. Number, percentage of patients. Treatment (n=30): 86.7.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Technical Success Outcome Measure 1 [Index Procedure]. Number, percentage of patients. Treatment (n=30): 100.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Clinical Success Outcome Measure [30 or 60 days post-procedure]. Number, percentage of patients. Treatment (n=30): 83.3.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Safety/Adverse Event Outcome Measure 2 [Index procedure through 1-week post-stent removal]. Number, percentage of patients. Treatment (n=30): 100.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Safety/Adverse Event Outcome Measure 3 [Index procedure through 1-week post-stent removal]. Number, percentage of patients. Treatment (n=30): 100.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Safety/Adverse Event Outcome 4 [Index procedure through 1-week post-stent removal]. Number, percentage of patients. Treatment (n=28): 96.4.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Safety/Adverse Event Outcome Measure 5 [Index procedure through 1-week post-stent removal]. Number, percentage of patients. Treatment (n=28): 100.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Safety/Adverse Event Outcome Measure 6 [Index procedure through 1-week post-stent removal]. Number, percentage of patients. Treatment (n=30): 93.3.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Technical Success Outcome Measure 2 [30 or 60 Day Post-procedure]. Number, percentage of patients. Treatment (n=27): 100.