NCT01434771

Withdrawn

Monitoring Blood Flow and Breathing Using a New Device (RFII...

University of Florida Source

University of Florida

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

20110031

Study Type

observational

Actual enrollment (reported)

0

Locations

0 countries

Sites

N/A

Timeline

Study Start

December 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2012

Actual (reported)

Study Completion

December 2012

Actual (reported)

Brief Summary

The purpose of this study will be to compare standard of care invasive methods to an FDA approved non-invasive device and a novel wireless non-invasive device, both manufactured by Non-Invasive Medical Technologies Inc., with the goal of correlating the data generated by the novel device to the measurements taken by the standard of care invasive monitors.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: withdrawn
Actual enrollment (reported): 0 participants
Study completion date: December 2012
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
September 13, 2011
Actual (reported)
First Posted
September 15, 2011
Actual (reported)
Study Start
December 2012
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)
Study Completion
December 2012
Actual (reported)

Last Updated: October 16, 2013
Status Verified: October 2013
Last Update Submitted: October 15, 2013

Conditions

Noninvasive Cardiac Monitoring

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients scheduled for open heart surgery

You may qualify if:

years and older
Weight - 36-136 Kilograms
Height - 1.52 meters - 1.92 meters (5'- 6'4")
Scheduled for open heart surgery during the study period

You may not qualify if:

Sponsors & Collaborators

Noninvasive Medical Technologies, Inc.
Industrycollaborator
United States Department of Defense
US federal agencycollaborator
University of Florida

Study Officials

Kevin L Ferguson, MD
University of Florida
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 13, 2011

First Posted

September 15, 2011

Study Start

December 2012

Date type not reported

This date has not been verified as actual or estimated.

ECG lead adhesive allergy or sensitivity

Pregnant Patients

Prisoners

Cognitively impaired

Patients requiring mechanical cardiac support, or requirement for hemodialysis

Patients not requiring pulmonary artery catheters for medical management.

Patients with significant valvular disease will be enrolled if there is no significant post-repair valvular dysfunction as determined by intraoperative transesophageal echocardiography

Contact the study team to confirm eligibility.

Otherlead

Primary Completion

December 2012

Actual (reported)

Study Completion

December 2012

Actual (reported)

Last Updated

October 16, 2013

Record last verified: 2013-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01434771
Data provider: ClinicalTrials.gov
Source updated: 2013-10-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:55 UTC

Study Stopped

Monitoring Blood Flow and Breathing Using a New Device (RFII) Compared to the Gold Standard Device in Post Operative Cardiac Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Officials

Enrollment

Study Design

Study Record Dates

Source record