Near-Infrared Spectroscopy for Pediatric Acute Scrotum and Testicular Torsion (NIRS)
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|ClinicalTrials.gov Identifier: NCT01812109|
Recruitment Status : Completed
First Posted : March 15, 2013
Results First Posted : January 29, 2021
Last Update Posted : January 29, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Acute Scrotum Testicular Torsion||Device: Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Those that accept study participation after informed consent will receive standard of care therapy for the acute scrotum and will be evaluated by NIRS. The NIRS measurements will not bias the treatments performed or not performed on the study patients, permitting standard of care treatment unbiased. The clinical data will be collected prospectively for each patient utilizing REDCap Data Collection Management and stored in the REDCap databases and the photographic database. Photographs will be taken of the scrotum. In addition, select participants will be asked if they will allow us to videotape the NIRS measurements.|
|Masking:||None (Open Label)|
The probe will be laid on the exposed testis (intraoperative testicular tissue). Each measurement is painless and takes <15 seconds each. The NIRS probe will be placed on the anterior testis to obtain the three sets of three measurements. Thus, the unaffected testis will serve as the patient's own control. NIRS #2-4 will not delay detorsion of the affected testis. Surgeons will be blinded to these NIRS results, thus the decision during the operation will not be affected.
All participants' NIRS results will be blinded to the surgeons.
|Official Title:||Near-Infrared Spectroscopy for Pediatric Acute Scrotum and Testicular Torsion|
|Actual Study Start Date :||March 24, 2011|
|Actual Primary Completion Date :||March 25, 2015|
|Actual Study Completion Date :||November 9, 2015|
Experimental: Hutchison Technologies Inspectra StO2 NIRS
Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy (NIRS) evaluation of acute scrotum per protocol
Device: Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy
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.
- Median NIRS Delta %StO2 [ Time Frame: Done at 1, 5 and 10 seconds ]
Testicular tissue percent oxygen saturation (%StO2) is measured by transscrotal near infrared spectroscopy (NIRS). This is similar to the PulseOx machine that is usually used when we go for a regular doctor visit.
NIRS measurements were obtained with Hutchison Technology InSpectra StO2 Spot Check Device (Model 300) with thenar clip probe (Model 1315, modified by clip removal).
Measurements were done at 1, 5 and 10 seconds to account for interassay variability, which is expected to be less than 3 %StO2. The average of the 3 readings was defined as the NIRS %StO2 reading for that testis. The NIRS readings in the affected testis were normalized to the contralateral normal testis to formulate a NIRS delta %StO2 (%StO2 of unaffected testis and %StO2 of affected testis). If the affected testis had lower %StO2 readings than the contralateral normal testis, NIRS delta %StO2 would be positive.
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|Ages Eligible for Study:||1 Month to 21 Years (Child, Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
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.
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812109
|United States, Texas|
|Children's Medical Center at Dallas|
|Dallas, Texas, United States, 75207|
|Principal Investigator:||Linda A Baker, MD||University of Texas|
|Responsible Party:||Linda A Baker, Professor of Urology, Director of Pediatric Urology Research, University of Texas Southwestern Medical Center|
|Other Study ID Numbers:||
1R21DK092654-01A1 ( U.S. NIH Grant/Contract )
|First Posted:||March 15, 2013 Key Record Dates|
|Results First Posted:||January 29, 2021|
|Last Update Posted:||January 29, 2021|
|Last Verified:||January 2021|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
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