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Near-Infrared Spectroscopy for Pediatric Acute Scrotum and Testicular Torsion (NIRS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01812109
Recruitment Status : Completed
First Posted : March 15, 2013
Results First Posted : January 29, 2021
Last Update Posted : January 29, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Linda A Baker, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Acute Scrotum
Testicular Torsion
Intervention Device: Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy
Enrollment 154
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NIRS
Hide Arm/Group Description There is only 1 group in this non randomized pilot study. Those patients with acute scrotum defined as painful scrotum or testes, abdominal pain +/- nausea and vomiting, waddling gain (cowboy shuffle) .
Period Title: Overall Study
Started 154
With Torsion 36
Without Torsion 85
Completed 121
Not Completed 33
Reason Not Completed
research personnel delay             16
NIRS Unattainable             17
Arm/Group Title NIRS
Hide Arm/Group Description There is only 1 group in this non randomized pilot study. Those patients with acute scrotum defined as painful scrotum or testes, abdominal pain +/- nausea and vomiting, waddling gain (cowboy shuffle) .
Overall Number of Baseline Participants 121
Hide Baseline Analysis Population Description
17 participants were excluded from the analysis as the NIRS reading could not be obtained.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants
11.8  (3.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants
Female
0
   0.0%
Male
121
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 121 participants
White
23
  19.0%
Hispanic
79
  65.3%
Black
15
  12.4%
Asian
1
   0.8%
Other
3
   2.5%
1.Primary Outcome
Title Median NIRS Delta %StO2
Hide Description

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.
Time Frame Done at 1, 5 and 10 seconds
Hide Outcome Measure Data
Hide Analysis Population Description
Here we are reporting Median NIRS delta %StO2 with Torsion and without torsion.
Arm/Group Title Hutchison Technologies Inspectra StO2 NIRS
Hide Arm/Group Description:

Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy (NIRS) evaluation of acute scrotum per protocol

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.
Overall Number of Participants Analyzed 121
Median (Inter-Quartile Range)
Unit of Measure: percentage of StO2
Torsion Number Analyzed 36 participants
2.0
(-4.2 to 9.8)
No Torsion Number Analyzed 85 participants
-1.7
(-8.7 to 2.0)
Time Frame Baseline upto 2weeks post -op.
Adverse Event Reporting Description No Adverse events occurred in this study.
 
Arm/Group Title Hutchison Technologies Inspectra StO2 NIRS
Hide Arm/Group Description

Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy (NIRS) evaluation of acute scrotum per protocol

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.
All-Cause Mortality
Hutchison Technologies Inspectra StO2 NIRS
Affected / at Risk (%)
Total   0/154 (0.00%) 
Hide Serious Adverse Events
Hutchison Technologies Inspectra StO2 NIRS
Affected / at Risk (%)
Total   0/154 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hutchison Technologies Inspectra StO2 NIRS
Affected / at Risk (%)
Total   0/154 (0.00%) 
Different NIRS probes may be needed for prepubertal vs postpubertal testis and further research is needed to optimize NIRS device configuration.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Linda Baker
Organization: University of Texas Southwestern Medical Center
Phone: 214/456-2480
EMail: Linda.baker@childrens.com
Publications of Results:
Sheth KR, Keays M, Grimsby GM, Granberg CF, Menon VS, DaJusta DG, Ostrov L, Hill M, Sanchez E, Kuppermann D, Harrison CB, Jacobs MA, Huang R, Burgu B, Hennes H, Schlomer BJ, Baker LA. Diagnosing Testicular Torsion before Urological Consultation and Imaging: Validation of the TWIST Score. J Urol. 2016 Jun;195(6):1870-6. doi: 10.1016/j.juro.2016.01.101. Epub 2016 Feb 2.
Schlomer BJ, Keays MA, Grimsby GM, Granberg CF, DaJusta DG, Menon VS, Ostrov L, Sheth KR, Hill M, Sanchez EJ, Harrison CB, Jacobs MA, Huang R, Burgu B, Hennes H, Baker LA. Transscrotal Near Infrared Spectroscopy as a Diagnostic Test for Testis Torsion in Pediatric Acute Scrotum: A Prospective Comparison to Gold Standard Diagnostic Test Study. J Urol. 2017 Sep;198(3):694-701. doi: 10.1016/j.juro.2017.03.134. Epub 2017 Apr 6.
Grimsby GM, Schlomer BJ, Menon VS, Ostrov L, Keays M, Sheth KR, Villanueva C, Granberg C, Dajusta D, Hill M, Sanchez E, Harrison CB, Jacobs MA, Burgu B, Hennes H, Baker LA. Prospective Evaluation of Predictors of Testis Atrophy After Surgery for Testis Torsion in Children. Urology. 2018 Jun;116:150-155. doi: 10.1016/j.urology.2018.03.009. Epub 2018 Mar 20.
Other Publications:
Layout table for additonal information
Responsible Party: Linda A Baker, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01812109    
Other Study ID Numbers: STU 102010-133
1R21DK092654-01A1 ( U.S. NIH Grant/Contract )
First Submitted: January 24, 2013
First Posted: March 15, 2013
Results First Submitted: November 24, 2020
Results First Posted: January 29, 2021
Last Update Posted: January 29, 2021