Status:
COMPLETED
Near-Infrared Spectroscopy for Pediatric Acute Scrotum and Testicular Torsion
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Acute Scrotum
Testicular Torsion
Eligibility:
MALE
1-21 years
Phase:
NA
Brief Summary
Testicular torsion is the spontaneous twisting of the testis and its blood vessels, resulting in acute pain, vascular compromise and death of the testicle if unrelieved quickly. In this study, investi...
Detailed Description
The main goal of this prospective, non-randomized pilot study is to assess the utility of NIRS for the clinical diagnosis of the acute scrotum and testicular torsion. The sensitivity and specificity o...
Eligibility Criteria
Inclusion
- Males one month to 21 years of age with:
- Painful acute scrotum or testis OR Abdominal pain (+/- nausea, vomiting) and waddling gait ("cowboy shuffle") from painful scrotum.
Exclusion
- Males with:
- Synchronous bilateral testicular torsion History of known testicular or scrotal surgery Current hernia or painless hydrocele Current obvious scrotal bug bites History of chronic respiratory, hematological or vascular problems that will affect total body tissue oxygenation levels (Home oxygen).
Key Trial Info
Start Date :
March 24 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2015
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT01812109
Start Date
March 24 2011
End Date
November 9 2015
Last Update
May 24 2024
Active Locations (1)
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1
Children's Medical Center at Dallas
Dallas, Texas, United States, 75207