CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 154 enrolled
Drug / intervention
Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT01812109N/ACompleted
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Near-Infrared Spectroscopy for Pediatric Acute Scrotum and Testicular Torsion

University of Texas Southwestern Medical Center·interventional·Posted Mar 15, 2013·Updated May 24, 2024

In Brief

A clinical study evaluating Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy for Acute Scrotum and Testicular Torsion. Completed, enrolled 154 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Scrotum, Testicular Torsion
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 15, 2013
Enrollment StartMar 24, 2011
Primary CompletionMar 25, 2015
Study CompletionNov 9, 2015
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 13.3 years ago

Interventions

Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopydevice

Device: Near-Infrared Spectroscopy Transscrotal NIRS is a series of 6 transcutaneous scrotal measurements, 3 on both left/right. Each measurement is completely non-invasive, painless and takes \~15 seconds each. Thus, no sedation or supplemental analgesia is needed for NIRS. The NIRS probe will be placed on the anterior, lateral and posterior scrotum on the left/right sides, immediately overlying and parallel to the long axis of the testis but on the skin to obtain the 6 total measurements. The unaffected testis will serve as the patient's own control. Study coordinators will be performing the ER transscrotal NIRS testing. For uniformity, all will be trained for testicular probe placement methods. NIRS will not delay the gray scale/color Doppler testicular US or surgery.