Near-Infrared Spectroscopy for Pediatric Acute Scrotum and Testicular Torsion

NCT01812109 | Completed Results DMC FDA Device

• 2 other identifiers: STU 102010-1331R21DK092654-01A1
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Scrotum; Testicular Torsion

Keywords

Testicular Torsion

Outcome Measures

Primary Outcomes (1)

• Median NIRS Delta %StO2

  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.

  Done at 1, 5 and 10 seconds

Study Arms (1)

Hutchison Technologies Inspectra StO2 NIRS

EXPERIMENTAL

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

Device: Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy

Interventions

Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy DEVICE

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.

Hutchison Technologies Inspectra StO2 NIRS

Eligibility Criteria

• Age: 1 Month - 21 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Children's Medical Center at Dallas

Dallas, Texas, 75207, United States

Location

Related Publications (4)

• DaJusta DG, Granberg CF, Villanueva C, Baker LA. Contemporary review of testicular torsion: new concepts, emerging technologies and potential therapeutics. J Pediatr Urol. 2013 Dec;9(6 Pt A):723-30. doi: 10.1016/j.jpurol.2012.08.012. Epub 2012 Oct 6.

  PMID: 23044376 BACKGROUND

• 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.

  PMID: 26835833 RESULT

• 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.

  PMID: 28392394 RESULT

• 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.

  PMID: 29572055 RESULT

MeSH Terms

Conditions

Spermatic Cord Torsion

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

Different NIRS probes may be needed for prepubertal vs postpubertal testis and further research is needed to optimize NIRS device configuration.

Results Point of Contact

• Title: Dr. Linda Baker
• Organization: University of Texas Southwestern Medical Center

Linda.baker@childrens.com

214/456-2480

Study Officials

• Linda A Baker, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology, Director of Pediatric Urology Research

Model Details: 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.

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: March 15, 2013
• Study Start: March 24, 2011
• Primary Completion: March 25, 2015
• Study Completion: November 9, 2015
• Last Updated: May 24, 2024
• Results First Posted: January 29, 2021

Record last verified: 2024-05

Locations

US (1)