Percutaneous Access
Conditions
Keywords
ultrasound guided percutaneous access
Brief summary
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.
Interventions
DEVICEMendaera 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.
Sponsors
Mendaera, Inc
CBCC Global Research LLP
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For all procedures: * Age ≥ 18 years * Subject or legal representative is willing and able to provide informed consent * Subject is willing and able to comply with protocol follow-up * Elective procedure (non-emergent) For organ access procedures, one of the following must apply: * Subjects for whom a percutaneous renal access for nephrostomy tube placement or percutaneous nephrolithotomy have has been indicated * Subjects for whom a percutaneous biopsy have has been indicated * Subjects for whom a percutaneous drainage (e.g. paracentesis, thoracentesis, etc.) have has been indicated For vascular access procedures: • Subjects for whom a vascular access (arterial or venous) have been indicated For pain management injections procedures: • Subjects for whom a pain management injection procedure has been indicated, such as intra-articular injection, nerve block pre- or post- operatively, and epidural
Exclusion criteria
* For all procedures: * Subject refusal * Subject is unstable or potentially unstable * Known significant coagulopathy (INR \>2.0, platelet count \<100,000 / µL) * Previous failed attempt of same procedure * Suspected infection at intended needle insertion or target site * BMI \>35 kg/m² * Subject has any other medical, social, or psychological problem that, in the opinion of the Investigator, precludes them from participating * Subject who is pregnant or intends to become pregnant during the study * Hypertension (subject blood pressure ≥180/110mmHg) * History of venous thrombosis For organ access procedures: * Known anatomic abnormalities of target organ * Subject underwent transplant or urinary diversion * Abnormal kidney function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Device-Related Adverse Events (occurrence and severity) | 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 | Participant enrollment through 24 hour follow-up (+/- 12 hours) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time for relevant sub-steps of the procedure, including setup, draping, and access | 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 | 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? |
Countries
United States
Outcome results
None listed