Hydronephrosis ARFI Study
This study is currently recruiting participants.
Verified January 2013 by University of Michigan
Sponsor:
University of Michigan
Information provided by (Responsible Party):
Jonathan R. Dillman M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01781845
First received: January 30, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | January 30, 2013 | ||||
| Last Updated Date | January 30, 2013 | ||||
| Start Date ICMJE | November 2012 | ||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
ARFI-SVI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] fibrosis and intratubular pressure will be evidenced by higher parenchymal shear wave velocity measurements using the ARFI-SVI technology. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Hydronephrosis ARFI Study | ||||
| Official Title ICMJE | Evaluation of Ultrasound Acoustic Radiation Force Impulse (ARFI)Shear Wave Velocity Imaging (SVI)in the Characterization of Pediatric Hydronephrosis | ||||
| Brief Summary | Pediatric upper urinary tract dilatation (hydronephrosis) is relatively common and may be either obstructive or nonobstructive. While the upper urinary tract is commonly evaluated by ultrasound, this imaging technique often fails to distinguish obstructed from nonobstructed systems. ARFI SVI is a new ultrasound technology that can be used to determine stiffness by measuring a tissue's shear wave velocity, may show alterations in parenchymal shear wave velocity in kidneys that show obstruction on DRS (Diuretic renal scintigraphy)which serves as the reference standard. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Hydronephrosis | ||||
| Intervention ICMJE | Procedure: AFRI-SVI Ultrasound
This research scan uses acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI)a new ultrasound technology in which unique sound waves create the images/pictures of the kidney beng examined/scanned. This ultrasound scan will take approximately 10 minutes to complete. |
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| Study Arm (s) | Experimental: ARFI-SVI Ultrasound
Ultrasound scan using acoustic radiation force impulse-shear wave velocity imaging in the characterization of pediatric hydronephrosis. This is a non-invasive scan that uses sound waves to create the images.
Intervention: Procedure: AFRI-SVI Ultrasound |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | January 2016 | ||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: None - |
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| Gender | Both | ||||
| Ages | up to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01781845 | ||||
| Other Study ID Numbers ICMJE | HUM00064524 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Jonathan R. Dillman M.D., University of Michigan | ||||
| Study Sponsor ICMJE | University of Michigan | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Michigan | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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