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Robot arm aims to make needle procedures safer and more precise

NCT ID NCT07358351

Knowledge-focused Sponsor: Mendaera, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a robotic device that helps doctors place needles or other instruments during ultrasound-guided procedures, like biopsies or kidney drainage. About 46 adults who need such a procedure will take part. The main goals are to see if the device is safe and if it can successfully guide the instrument to the right spot. This is an early feasibility study, so it's mainly about checking if the idea works, not yet proving it improves patient outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mendaera Guidance System (robotic device for ultrasound-guided needle placement)
What this could lead to
If successful, this could lead to a tool that makes common needle procedures (like biopsies) more precise and easier for doctors.
What could go wrong
This is a small, early feasibility study with only 46 participants. The device may not work better than standard methods, and there could be unexpected technical issues or complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

46 people

The number who actually took part.

Started

Dec 2025

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants undergoing an ultrasound-guided procedure

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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Contacts and locations

Locations

  • Mendaera, Inc

    San Mateo, California, 94402, United States