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Near-Infrared Spectroscopy for Pediatric Acute Scrotum and Testicular Torsion

NCT01812109 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-05-24

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Linda A Baker, MD · University of Texas

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-24
Primary Completion
2015-03-25
Completion
2015-11-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01812109 on ClinicalTrials.gov