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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
Last Update Posted : October 16, 2018
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

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Scrotum Testicular Torsion Device: Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy Not Applicable

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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)
Masking Description:

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.

Primary Purpose: Diagnostic
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).


Information from the National Library of Medicine

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


Locations
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United States, Texas
Children's Medical Center at Dallas
Dallas, Texas, United States, 75207
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Linda A Baker, MD University of Texas

Publications of Results:
Other Publications:
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Responsible Party: Linda A Baker, Professor and Interim Chief of Urology, Director of Pediatric Urology Research, 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 Posted: March 15, 2013    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Keywords provided by Linda A Baker, University of Texas Southwestern Medical Center:
Testicular Torsion
Additional relevant MeSH terms:
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Spermatic Cord Torsion
Torsion Abnormality
Pathological Conditions, Anatomical
Genital Diseases, Male