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Point-of-Care Computed Tomography (CT) Chronic Rhinosinusitis 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: NCT00871286
Recruitment Status : Completed
First Posted : March 30, 2009
Results First Posted : January 18, 2012
Last Update Posted : January 18, 2012
Sponsor:
Information provided by (Responsible Party):
Rakesh Chandra, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Chronic Rhinosinusitis
Interventions Procedure: Pre-treatment Sinus CT Scan
Procedure: Post-treatment Sinus CT Scan
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CT Scan (Sinus) Pre-tx CT Scan (Sinus) Post-tx
Hide Arm/Group Description Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event. Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
Period Title: Overall Study
Started 20 20
Completed 20 14
Not Completed 0 6
Arm/Group Title CT Scan (Sinus) Pre-tx CT Scan (Sinus) Post-tx Total
Hide Arm/Group Description Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event. Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event. Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
39  (13.5) 38.9  (11.6) 39  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
13
  65.0%
16
  80.0%
29
  72.5%
Male
7
  35.0%
4
  20.0%
11
  27.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Number of Participants in Compliance With Medical Recommendations
Hide Description Number of participants in each group who complied with medical advice given at the initial appointment.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CT Scan (Sinus) Pre-tx CT Scan (Sinus) Post-tx
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
20 10
2.Primary Outcome
Title Number of Participants Having a CT Done
Hide Description Total number of participants having a CT scan (sinus) done in each of the two groups over the study interval.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol; this was a nonpowered convenience sample
Arm/Group Title CT Scan (Sinus) Pre-tx CT Scan (Sinus) Post-tx
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
20 9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CT Scan (Sinus) Pre-tx CT Scan (Sinus) Post-tx
Hide Arm/Group Description Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event. Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
All-Cause Mortality
CT Scan (Sinus) Pre-tx CT Scan (Sinus) Post-tx
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
CT Scan (Sinus) Pre-tx CT Scan (Sinus) Post-tx
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CT Scan (Sinus) Pre-tx CT Scan (Sinus) Post-tx
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rakesh Chandra
Organization: Northwestern
Phone: 312-695-8182
EMail: rchandra@nmff.org
Layout table for additonal information
Responsible Party: Rakesh Chandra, Northwestern University
ClinicalTrials.gov Identifier: NCT00871286    
Other Study ID Numbers: STU 8997
STU 8997
First Submitted: March 26, 2009
First Posted: March 30, 2009
Results First Submitted: August 29, 2011
Results First Posted: January 18, 2012
Last Update Posted: January 18, 2012