Feasibility of Robotic Instrument Guidance System to Perform Safe Ultrasound-Guided Percutaneous Procedures During Routine Medical Procedures.

NCT07358351 · tracked via the Priya Life Science USA tracker

Sponsor

Mendaera, Inc

Phase

Observational

Started

2025-12-03

Last updated

2026-01-22

Condition(s) studied

Percutaneous Access

Investigational drug(s) / intervention(s)

Mendaera Guidance System

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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)

Trial sites (1)

Facility	City	Region	Status
Mendaera, Inc	San Mateo	California

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07358351 on ClinicalTrials.gov ↗ ← All trials in the USA