Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Patient Comfort With Vascular Closure

This study has been completed.
Access Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Florida Identifier:
First received: October 19, 2009
Last updated: December 5, 2011
Last verified: November 2011
Results First Received: September 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Vascular Closure
Interventions: Device: Mynx Vascular Closure Device
Device: AngioSeal Vascular Closure Device

  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
Participants were recruited from the clinical practice of the investigator between November 2009 and July 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who had any groin pain before placement of the closure device were excluded.

Reporting Groups
Mynx VCD Mynx Vascular Closure Device
AngioSeal VCD AngioSeal Vascular Closure Device

Participant Flow:   Overall Study
    Mynx VCD     AngioSeal VCD  
STARTED     32     32  
COMPLETED     32     32  
NOT COMPLETED     0     0  

  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.
No text entered.

Reporting Groups
Mynx VCD Mynx Vascular Closure Device
AngioSeal VCD AngioSeal Vascular Closure Device
Total Total of all reporting groups

Baseline Measures
    Mynx VCD     AngioSeal VCD     Total  
Number of Participants  
[units: participants]
  32     32     64  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     26     22     48  
>=65 years     6     10     16  
[units: participants]
Female     22     19     41  
Male     10     13     23  
Region of Enrollment  
[units: participants]
United States     32     32     64  

  Outcome Measures
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1.  Primary:   Mean Score on the Visual Analogue Scale   [ Time Frame: Immediately before vascular closure and immediately after vascular closure. ]

2.  Secondary:   Major Complications   [ Time Frame: 1 Day ]

  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
The Angio-Seal Evolution is only one of a variety of potential vascular closure devices available on the market that would be suitable for comparison with the Mynx; however, this study was limited to just one of such alternative devices.

  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: J Mocco, M.D.
Organization: University of Florida
phone: 352-273-9000

No publications provided

Responsible Party: University of Florida Identifier: NCT00998023     History of Changes
Other Study ID Numbers: 479-2009
Study First Received: October 19, 2009
Results First Received: September 21, 2011
Last Updated: December 5, 2011
Health Authority: United States: Institutional Review Board