NCT05962905Completed
Accuracy Performance Verification of the INVOS™ System in Pediatrics
Medtronic Accuracy Performance Verification of the INVOS™ System in the Pediatric Cardiac Catheterization Laboratory (INCATH)
Source: ClinicalTrials.gov · Last updated 9 May 2025
Brief summary (registry, in English)
Prospective, observational, multi-center trial designed to capture calibration and performance evaluation data with the INVOS™ system.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 110 (actual)
- First submitted
- 13 Jul 2023
- Start date
- 16 Nov 2023
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- Medtronic - MITG
- NCT number
- NCT05962905
What you commit to
- Study type: Observational
- Participants enrolled: 110
- From 16 Nov 2023 to the primary completion date, 30 Nov 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \[self-reported\]
Other illness
- A skin condition at the sensor site (e.g., rash, abrasion, laceration)
- Craniofacial disease producing abnormal forehead anatomy and/or preventing forehead application of the sensor
- Cerebrovascular disease
- An emergent, life threatening condition impacting study conduct
Lab values
- Currently receiving phototherapy for bilirubin
Other
- A known structural brain lesion beneath the sensor
- Known hemoglobinopathy
- Inability to lie supine with neutral neck position during catheterization
- Unwillingness or inability to sign informed consent (IC) or assent by the parents/guardians of child
- Arterial or venous anatomy that would preclude obtaining an accurate paired sample
- Known pregnancy
Who the study is looking for
- Under 21 years of age
- Meets weight requirement for sensors under study
- Scheduled for a diagnostic or interventional cardiac catheterization procedure with general anesthesia or sedation
- Arterial and venous access as part of the planned catheterization procedure
Age in the registry: 0 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Children's Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Children's Mercy Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Seattle Children's Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Washington University St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.