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

Mendaera, Inc

Status: Active, not recruiting

Conditions: Percutaneous Access

Treatments: Device: Mendaera Guidance System

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT07358351

100-00012-PROTOCOL-01

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

46 participants in 1 patient group

Prospective, single-center, single-arm

Description:

single arm

Treatment:

Device: Mendaera Guidance System