Percutaneous AccessACCESSNCT07358351
Feasibility of Robotic Instrument Guidance System to Perform Safe Ultrasound-Guided Percutaneous Procedures During Routine Medical Procedures.
An observational study of Percutaneous Access, run by Mendaera, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Access
- What is being tested?
- Mendaera Guidance System
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2025to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants undergoing an ultrasound-guided procedure
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Percutaneous Access
- Being tested
- Mendaera Guidance System
- Keywords
- ultrasound guided percutaneous access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mendaera Guidance SystemDevice
Also called Ultrasound 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 group | Role | What they receive |
|---|---|---|
| Prospective, single-center, single-arm | single arm Receives: Device: Mendaera Guidance System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Device-Related Adverse Events (occurrence and severity)
Measured: 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
Measured: Participant enrollment through 24 hour follow-up (+/- 12 hours)
Secondary outcomes (2)
Time for relevant sub-steps of the procedure, including setup, draping, and access
Measured: 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?
Measured: Participant enrollment through 24 hour follow-up (+/- 12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start3 Dec 2025
- Primary completion12 Dec 2025
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percutaneous AccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mendaera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research LLP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358351
- Sponsor's protocol ID
- 100-00012-PROTOCOL-01
- Acronym
- ACCESS
- Status last verified
- Dec 2025
- First submitted
- 26 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Singh A, Jain S, Kukreja K, Patil A, Ganpule A, Sabnis R, Desai M, Desai M. Robotic guidance for ultrasound-guided percutaneous procedures: a prospective multispecialty feasibility study. World J Urol. 2026 Jul 25;44(1):517. doi: 10.1007/s00345-026-06618-4.
PubMed 42501105
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Robotic Instrument Guidance System to Perform Safe Ultrasound-Guided Percutaneous Procedures
- ClinicalTrials.gov ID
- NCT07358351
- Acronym / sponsor ID
- ACCESS / 100-00012-PROTOCOL-01
- Conditions
- Percutaneous Access
- Keywords
- ultrasound guided percutaneous access
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Mendaera, IncIndustry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research LLP
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- Feb 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective, single-center, single-arm | – | Device: Mendaera Guidance Systemsingle arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants undergoing an ultrasound-guided procedure
Key inclusion criteria (13 listed)
- 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)
- Subjects for whom a percutaneous renal access for nephrostomy tube placement or percutaneous nephrolithotomy have has been indicated
Key exclusion criteria (15 listed)
- For all procedures:
- Known anatomic abnormalities of target organ
- Subject underwent transplant or urinary diversion
- Abnormal kidney function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mendaera Guidance SystemAlso: Ultrasound guidance systemPrecise 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. | Device | Prospective, single-center, single-arm |
Primary outcome
Number of Participants With Device-Related Adverse Events (occurrence and severity)
Time frame: 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
Time frame: Participant enrollment through 24 hour follow-up (+/- 12 hours)
2 secondary outcomes
Time for relevant sub-steps of the procedure, including setup, draping, and access
Time frame: 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
Time frame: Participant enrollment through 24 hour follow-up (+/- 12 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Derived from this study: PubMed 42501105Singh A, Jain S, Kukreja K, Patil A, Ganpule A, Sabnis R, Desai M, Desai M. Robotic guidance for ultrasound-guided percutaneous procedures: a prospective multispecialty feasibility study. World J Urol. 2026 Jul 25;44(1):517. doi: 10.1007/s00345-026-06618-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Access, run by Mendaera, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Device-Related Adverse Events (occurrence and severity) (time frame: From enrollment to 24 hour follow-up (+/- 12 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07358351, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.