N/A N=154 Diagnostic

Near-Infrared Spectroscopy for Pediatric Acute Scrotum and Testicular Torsion

Acute Scrotum · Testicular Torsion

Bottom Line

View on ClinicalTrials.gov: NCT01812109 ↗

Enrolled (actual)

154

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcome: Primary: Median NIRS Delta %StO2 — 2.0; -1.7 percentage of StO2

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy (Device)
Age: Pediatric, Adult · 0+ yrs
Sex: Male
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Median NIRS Delta %StO2	2.0; -1.7	—

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, investigators will test a near-infrared spectroscopy (NIRS) device that rapidly and non-invasively measures deep tissue oxygen saturation.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01812109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.