Angel® Catheter Early Feasibility Clinical Study

Not Applicable

Terminated

• Conditions: Deep Vein Thrombosis; Pulmonary Embolism; Venous Thromboembolism
• Interventions: Device: Angel® Catheter

• Registration Number: NCT01847196
• Lead Sponsor: BiO2 Medical

Brief Summary

The primary objective of this clinical trial is to obtain initial insights into the safety of the Angel® Catheter in critically ill subjects with high risk of venous thromboembolism (VTE) disease AND who are not receiving pharmacological thromboprophylaxis.

Detailed Description

STUDY ENDPOINTS

1. Primary Endpoints:

a. Initial Insights into Safety

* Success in delivery, maintenance and removal of the Angel® Catheter.

* Incidence and seriousness of all adverse events.

* Incidence of device or procedure-related adverse events.

2. Secondary Endpoints:

* Evaluation of the separate and combined functions of the IVC filter and the central venous catheter device.

* Evaluate investigative site's ability to comprehend the procedural steps (Per the Insertion Procedure, the Repositioning Procedure, and the Removal Procedure)

* Evaluate operator challenges with device use (human factors).

* Evaluate success and challenges encountered in conducting a pivotal trial in critically ill patient population - including but not limited to Informed Consent and enrollment.

ENROLLMENT AND SUBJECT SAMPLE SIZE

The study is expected to enroll up to 20 subjects in up to 4 US investigational sites with a goal for 10 evaluable subjects in whom Angel® Catheter placement has been attempted.

STUDY DURATION

The device is designed to be deployed for less than 30 days. After enrollment and Angel® Catheter placement, subjects will be followed daily through the post-removal, seven (7) day follow up or until hospital discharge, whichever occurs first.

Study Timeline

• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-05-02
• Study First Posted: 2013-05-06
• Study Start: 2013-11
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2015-02-18
• Results First Submitted QC: 2015-07-20
• Status Verified: 2015-08
• Results First Posted: 2015-08-14
• Last Update Submitted: 2015-08-14
• Last Update Posted: 2015-08-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Angel® Catheter	Angel® Catheter	All eligible subjects will receive an Angel® Catheter.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events Occuring for All Evaluable Subjects	From the time of subject enrollment through study exit (7 days post-removal or hospital discharge, whichever occurs first), for up to 37 days	All Adverse Events (AEs) occurring throughout the study will be identified and characterized by seriousness, relationship to the investigational device and/or procedure, and whether un/anticipated.

Secondary Outcome Measures

Name	Time	Method
Device Performance	From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days

Trial Locations

Locations (4)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

University of Texas Southwestern Medical Center - Dallas; 🇺🇸 Dallas, Texas, United States

University of Texas Houston; 🇺🇸 Houston, Texas, United States