Near-Infrared Spectroscopy for Pediatric Acute Scrotum and Testicular Torsion (NCT01812109) | Clinical Trial Compass
CompletedNot Applicable
Near-Infrared Spectroscopy for Pediatric Acute Scrotum and Testicular Torsion
United States154 participantsStarted 2011-03-24
Plain-language 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.
Who can participate
Age range
1 Month – 21 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Median NIRS Delta %StO2
Timeframe: Done at 1, 5 and 10 seconds
Trial details
NCT IDNCT01812109
SponsorUniversity of Texas Southwestern Medical Center