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NCT01352676 · ClinicalTrials.gov registry record
Limit Computed Tomography (CT) Scanning in Suspected Renal Colic
A clinical trial, sponsored by Yale University.
- Completed
- Registry status
- 635
- Enrollment target
NCT01352676: Completed study, sponsored by Yale University.
NCT01352676 is a clinical trial that has completed, run by Yale University. The registered enrollment target is 635 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01352676 has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- 635 participants
- Enrollment target
Study Summary
Computed tomography (CT) scanning is overused, expensive, and causes cancer. CT scan utilization in the U.S. has increased from an estimated 3 million CTs in 1980 to 62 million per year in 2007. From 2000 through 2006, Medicare spending on imaging more than doubled to $13.8 billion with advanced imaging such as CT scanning largely responsible. CT represents only 11% of radiologic examinations but is responsible for two-thirds of the ionizing radiation associated with medical imaging in the U.S. Recent estimates suggest that there will be 12.5 cancer deaths for every 10,000 CT scans. Renal colic is a common, non-life-threatening condition for which CT is overused. As many as 12% of people will have a kidney stone in their lifetime, and more than one million per year will present to the emergency department (ED). CT is now a first line test for renal colic, and is very accurate. However, 98% of kidney stones 5mm or smaller will pass spontaneously, and CT rarely alters management. A decision rule is needed to determine which patients with suspected renal colic require CT. While the signs and symptoms of renal colic have been shown to be predictable, no rule has yet been rigorously derived or validated to guide CT imaging in renal colic. A subset of patients with suspected renal colic may have a more serious diagnosis or a kidney stone that will require intervention; however the investigators maintain that clinical criteria, point of care ultrasound and plain radiography (when appropriate), will provide a more comparatively effective and safer approach by appropriately limiting imaging.
Primary Outcome
both the CT results and the follow-up documentation will be reviewed by two separate MD observers who are blinded to both the predictor variables and the outcome of the decision rule. CT results will be categorized as defined above, and intervention as defined above will either be considered present (immediate or delayed) or absent based on follow-up documentation. In the case where there is a discrepancy in the categorization of CT or intervention, a third reviewer will be used as a tie-breaker
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 635 participants |
| Start Date | 2011-05 |
| Est. Completion | 2014-03 |
What the finished NCT01352676 record still lists
NCT01352676 is an observational study that tracks outcomes without assigning an intervention. The registered 635 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01352676 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01352676 about?
NCT01352676 is a clinical study titled "Limit Computed Tomography (CT) Scanning in Suspected Renal Colic". Computed tomography (CT) scanning is overused, expensive, and causes cancer. CT scan utilization in the U.S. has increased from an estimated 3 million CTs in 1980 to 62 million per year in 2007. From 2000 through 2006, Medicare spending on imaging more than doubled to $13.8 billion with advanced ima...
What is the current status of trial NCT01352676?
This trial is currently completed. The enrollment target is 635 participants. The study started on 2011-05. Estimated completion is 2014-03.
Who is sponsoring clinical trial NCT01352676?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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