An observational study in Percutaneous Access, sponsored by Mendaera, Inc. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Mendaera, Inc · Observational
The Mendaera Guidance System ("Study Device") is intended to provide guidance for precise instrument placement of common percutaneous devices by positioning the device relative to the ultrasound transducer and the resulting image during a diagnostic or therapeutic procedure. After instrument placement is achieved, investigator will perform any further clinical tasks, procedures, or treatment using standard of care.
The target population for whom this device is intended includes participants requiring ultrasound guided, percutaneous procedures.
Participants who are scheduled to undergo an ultrasound-guided procedure will be consented and enrolled in the study.
Prior to the study procedure, participants should be prepared for ultrasound-guided procedure using standard of care.
Once the investigator determines that an ultrasound-guided procedure can be performed, the compatible percutaneous instrument will be connected to the Study Device, and the investigator may proceed to utilize the System to perform targeting and depth tracking of the instrument. Once access has been achieved, Participation will conclude after the first follow-up which is anticipated to be within 24±12 hours.
This is the only study on the registry with Mendaera, Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Participants undergoing an ultrasound-guided procedure
For all procedures:
For organ access procedures, one of the following must apply:
For vascular access procedures:
For pain management injections procedures:
Exclusion Criteria:
For all procedures:
For organ access procedures:
single arm
Device: Mendaera Guidance System
Precise instrument placement of common percutaneous access devices for participants undergoing an ultrasound-guided procedure. Placement is conducted during routine care where percutaneous access is required.
Also known as: Ultrasound guidance system
Number of Participants With Device-Related Adverse Events (occurrence and severity)
Time frame: From enrollment to 24 hour follow-up (+/- 12 hours)
Number of participants with technical success defined as successful instrument placement using the device for the indicated procedure, as determined by the provider performing the procedure
Time frame: Participant enrollment through 24 hour follow-up (+/- 12 hours)
Time for relevant sub-steps of the procedure, including setup, draping, and access
Time frame: Participant enrollment through 24 hour follow-up (+/- 12 hours)
Qualitative feedback and comparison of user's experience with the Mendaera system relative to standard of care
User experience feedback on a scale of 1- to 5. How does the Mendaera system compare relative to standard of care?
Time frame: Participant enrollment through 24 hour follow-up (+/- 12 hours)
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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