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

Feasibility of Robotic Instrument Guidance System to Perform Safe Ultrasound-Guided Percutaneous Procedures

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Percutaneous Access
• Intervention / Treatment: Device: Mendaera Guidance System

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• United States
  • California
    • San Mateo, California, United States, 94402
      • Mendaera, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants undergoing an ultrasound-guided procedure

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective, single-center, single-arm; 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.; Other Names: Ultrasound guidance system

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	User experience feedback on a scale of 1- to 5. How does the Mendaera system compare relative to standard of care?	Participant enrollment through 24 hour follow-up (+/- 12 hours)

Collaborators and Investigators

• Sponsor: Mendaera, Inc
• Collaborators: CBCC Global Research LLP

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2025
• Primary Completion (Actual): December 12, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: December 26, 2025
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: ultrasound guided percutaneous access
• Other Study ID Numbers: 100-00012-PROTOCOL-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes