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
Last Update Posted : October 16, 2018
|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 :||181 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.
- Testicular oxygen saturation (%StO2) [ Time Frame: Baseline, At surgery, One hour after surgery, 2 weeks postop ]
Baseline transcutaneous testicular %StO2 is at presentation to the ER for acute scrotum. Study personnel are blinded to results so as to not change standard of care. Baseline %StO2 will be compared to US diagnosis of torsion.
At surgery is direct testicular %StO2. One hour after surgery and two weeks postop are transcutaneous testicular %StO2.
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|