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Point-of-Care Computed Tomography (CT) Chronic Rhinosinusitis Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rakesh Chandra, Northwestern University
ClinicalTrials.gov Identifier:
NCT00871286
First received: March 26, 2009
Last updated: January 17, 2012
Last verified: January 2012
Results First Received: August 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Chronic Rhinosinusitis
Interventions: Procedure: Pre-treatment Sinus CT Scan
Procedure: Post-treatment Sinus CT Scan

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
CT Scan (Sinus) Pre-tx 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.
CT Scan (Sinus) Post-tx 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.

Participant Flow:   Overall Study
    CT Scan (Sinus) Pre-tx     CT Scan (Sinus) Post-tx  
STARTED     20     20  
COMPLETED     20     14  
NOT COMPLETED     0     6  



  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
CT Scan (Sinus) Pre-tx 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.
CT Scan (Sinus) Post-tx 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 Total of all reporting groups

Baseline Measures
    CT Scan (Sinus) Pre-tx     CT Scan (Sinus) Post-tx     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     20     40  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  39  ± 13.5     38.9  ± 11.6     39  ± 12.4  
Gender  
[units: participants]
     
Female     13     16     29  
Male     7     4     11  
Region of Enrollment  
[units: participants]
     
United States     20     20     40  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants in Compliance With Medical Recommendations   [ Time Frame: 8 weeks ]

2.  Primary:   Number of Participants Having a CT Done   [ Time Frame: 8 weeks ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Rakesh Chandra
Organization: Northwestern
phone: 312-695-8182
e-mail: rchandra@nmff.org


Publications:

Responsible Party: Rakesh Chandra, Northwestern University
ClinicalTrials.gov Identifier: NCT00871286     History of Changes
Other Study ID Numbers: STU 8997, STU 8997
Study First Received: March 26, 2009
Results First Received: August 29, 2011
Last Updated: January 17, 2012
Health Authority: United States: Institutional Review Board