Angel® Catheter Early Feasibility Clinical Study

This study has been terminated.
(IDE approval received for larger Pivotal Study)
Sponsor:
Information provided by (Responsible Party):
BiO2 Medical
ClinicalTrials.gov Identifier:
NCT01847196
First received: May 2, 2013
Last updated: August 14, 2015
Last verified: August 2015
Results First Received: February 18, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Pulmonary Embolism
Deep Vein Thrombosis
Venous Thromboembolism
Intervention: Device: Angel® Catheter

  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
For this study, enrollment was defined as the time of consent. There was a possibility that a consented subject could still become ineligible prior to Angel® Catheter placement. One (1) of the six (6) enrolled (i.e. consented) subjects became ineligible prior to Angel® Catheter placement, and did not go on to start the study.

Reporting Groups
  Description
Angel® Catheter

All eligible subjects received an Angel® Catheter.

The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge.


Participant Flow:   Overall Study
    Angel® Catheter  
STARTED     5 [1]
COMPLETED     5  
NOT COMPLETED     0  
[1] Includes all subjects in which Angel Catheter placement was attempted.



  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
  Description
Angel® Catheter

All eligible subjects received an Angel® Catheter.

The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge.


Baseline Measures
    Angel® Catheter  
Number of Participants  
[units: participants]
  5  
Age  
[units: years]
Mean (Standard Deviation)
  33.2  (10.4)  
Gender  
[units: participants]
 
Female     1  
Male     4  
Body Mass Index  
[units: kg/m^2]
Mean (Standard Deviation)
  25.8  (4.5)  
Trauma as Primary Reason for Hospital Admission  
[units: participants]
  5  
Baseline Venous Thromboembolism  
[units: participants]
 
No     5  
Yes     0  
Baseline Central Venous Catheter in Place  
[units: participants]
 
No     3  
Yes     2  
Subject on Mechanical Ventilation at Baseline  
[units: participants]
 
No     3  
Yes     2  
Subject on Vasopressors at Baseline  
[units: participants]
 
No     5  
Yes     0  
Subject on Dialysis at Baseline  
[units: participants]
 
No     5  
Yes     0  
Traumatic Brain Injury at Baseline  
[units: participants]
 
No     2  
Yes     3  
Subarachnoid and/or Subdural Bleeding at Baseline  
[units: participants]
 
No     3  
Yes     2  
Musculoskeletal Fractures at Baseline  
[units: participants]
 
No     1  
Yes     4  
Spinal Injury at Baseline  
[units: participants]
 
No     4  
Yes     1  
Respiratory Trauma or Distress at Baseline  
[units: participants]
 
No     1  
Yes     4  
Hepatic Trauma at Baseline  
[units: participants]
 
No     2  
Yes     3  
Multiple Fractures of Upper and Lower Limbs at Baseline  
[units: participants]
 
No     4  
Yes     1  
Spleen/Kidney Laceration at Baseline  
[units: participants]
 
No     3  
Yes     2  



  Outcome Measures
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1.  Primary:   Number of Adverse Events Occuring for All Evaluable Subjects   [ Time Frame: From the time of subject enrollment through study exit (7 days post-removal or hospital discharge, whichever occurs first), for up to 37 days ]

2.  Secondary:   Device Performance   [ Time Frame: From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 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
Due to the small number of patients, analysis is descriptive only.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Margaret Tumas, VP of Clinical Affairs
Organization: BiO2 Medical
phone: 720-635-3232
e-mail: mtumas@bio2medical.com



Responsible Party: BiO2 Medical
ClinicalTrials.gov Identifier: NCT01847196     History of Changes
Other Study ID Numbers: QD-155
Study First Received: May 2, 2013
Results First Received: February 18, 2015
Last Updated: August 14, 2015
Health Authority: United States: Food and Drug Administration