Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 87 of 150 for:    tetracycline

Tetra-NIRS Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00871975
Recruitment Status : Terminated (Low enrollment exceeding trial deadlines)
First Posted : March 30, 2009
Results First Posted : July 19, 2016
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Laborie Medical Technologies Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Lower Urinary Tract Symptoms
Overactive Bladder
Intervention Device: Urodynamics + TETRA - NIRS
Enrollment 155
Recruitment Details Each site recruited in a Urology clinic setting. All patients were scheduled for Urodynamics testing. Sunnybrook recruitment period spanned Apr 2010 - Feb 2012. Vanderbilt Sept 2009 - May 24 2010. King's College May 2010 - August 2010.
Pre-assignment Details There were no group assignments.
Arm/Group Title Urodynamics + Tetra-NIRS
Hide Arm/Group Description Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
Period Title: Overall Study
Started 155
Completed 133
Not Completed 22
Reason Not Completed
Technical difficulty w155-1ith equipment             3
Catheters could not be inserted             1
Patient unable to void/insufficient vol             13
Motion artifact, tracing uninterpretable             5
Arm/Group Title Urodynamics + Tetra-NIRS
Hide Arm/Group Description Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
Overall Number of Baseline Participants 155
Hide Baseline Analysis Population Description
Includes both male patients suffering from LUTS, and female patients suffering from OAB.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Greater than or equal to 18 years Number Analyzed 155 participants
155
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants
Female
121
  78.1%
Male
34
  21.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 155 participants
United States 18
Canada 37
United Kingdom 100
1.Primary Outcome
Title Number of Participants With Urodynamic Detrusor Overactivity Events or Prostatic Obstruction as Detected by Tetra-NIRS Compared to Urodynamics
Hide Description The Tetra-NIRS device provides a linear pattern similar to the pressures obtained during urodynamics. The NIRS output shows relative change in hemoglobin concentrations (oxygenated and deoxygenated) where the numerical value does not actually indicate the concentration, so there is no unit of measure. The numerical output is used to track change over time, or trendline analysis. A qualified interpreter studied tracings for significant changes (+/-2 Hb units) in the NIRS patterning during detrusor overactivity events. As well, under its' approved intended use, Tetra-NIRS trendline analysis was compared against urodynamics during voiding in males, such that a downward trend during voiding indicates urethral obstruction, and an upward trend indicates an unobstructed urethra.
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
Male and female patients were included, where the urodynamics tracings were compared against the Tetra NIRS tracings.
Arm/Group Title Urodynamics + Tetra NIRS
Hide Arm/Group Description:
Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: participants
True Positive on Tetra-NIRS + UDS 30
False Positive on Tetra-NIRS + UDS 59
False Negative on Tetra-NIRS + UDS 10
True Negatives on Tetra-NIRS + UDS 34
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Urodynamics + Tetra NIRS
Comments A contingency table was used to compare presence or absence of an event (eg. detrusor overactivity) on the urodynamic tracing with interpretation of events on the Tetra-NIRS tracings.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity (percent)
Estimated Value 80.6
Estimation Comments We found an 80.6% sensitivity for detection of detrusor overactivity on Tetra-NIRS as compared to urodynamics.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Urodynamics + Tetra NIRS
Comments A contingency table was used to compare presence or absence of an event (eg. detrusor overactivity) on the urodynamic tracing with interpretation of events on the Tetra-NIRS tracings.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Specificity (percent)
Estimated Value 28.1
Estimation Comments We found a 28.1% specificity for detection of detrusor overactivity on Tetra-NIRS as compared to urodynamics.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Urodynamics + Tetra-NIRS
Hide Arm/Group Description Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
All-Cause Mortality
Urodynamics + Tetra-NIRS
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Urodynamics + Tetra-NIRS
Affected / at Risk (%)
Total   0/155 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Urodynamics + Tetra-NIRS
Affected / at Risk (%)
Total   0/155 (0.00%) 
Early termination was due to slow recruitment exceeding trial deadlines. Technical issues resulted in several studies being excluded (8).
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
Layout table for Results Point of Contact information
Name/Title: Clinical Research Administrator
Organization: LABORIE
Phone: 905 612 1170 ext 2274
EMail: acampbell@laborie.com
Layout table for additonal information
Responsible Party: Laborie Medical Technologies Inc.
ClinicalTrials.gov Identifier: NCT00871975     History of Changes
Obsolete Identifiers: NCT00849225
Other Study ID Numbers: C001-C0015 TETRA-NIRS
First Submitted: March 26, 2009
First Posted: March 30, 2009
Results First Submitted: September 1, 2015
Results First Posted: July 19, 2016
Last Update Posted: July 19, 2016