Mendaera, Inc
San Mateo, California, 94402, United States
NCT Number: NCT07358351
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 study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
San Mateo, California, 94402, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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 organ access procedures:
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.
Other names: Ultrasound guidance system
Time frame: From enrollment to 24 hour follow-up (+/- 12 hours)
Time frame: Participant enrollment through 24 hour follow-up (+/- 12 hours)
Time frame: Participant enrollment through 24 hour follow-up (+/- 12 hours)
Time frame: Participant enrollment through 24 hour follow-up (+/- 12 hours)
User experience feedback on a scale of 1- to 5. How does the Mendaera system compare relative to standard of care?
Mendaera, Inc
Industry
Feasibility of Robotic Instrument Guidance System to Perform Safe Ultrasound-Guided Percutaneous Procedures
Acronym: ACCESS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.