No ConditionSmart NeedleNCT07302997
Real-Time Monitoring of the Injection Pressure During the Peripheral Nerve Block
A study testing Smart Needle Monitoring System in people with No Condition and Real-time Monitoring of the Injection Pressure During Ultrasound-guided Axillary Block, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
Trial summary
The goal of this clinical trial with medical device is to learn if the Smart Needle Monitoring System works to maintain a safe low injection pressure during a type of regional anaesthetic (Peripheral Nerve Block (PNB)) in patients due to undergo surgery below the elbow . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- No Condition, Real-time Monitoring of the Injection Pressure During Ultrasound-guided Axillary Block
- What is being tested?
- Smart Needle Monitoring System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Dec 2025to 14 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Informed Consent signed by the subject
- Age ≥ 18 years
- Scheduled for elective surgery below the elbow (e.g., hand surgery, distal radius surgery, forearm surgery) requiring an axillary block
- ASA physical status I-III
- Ability to understand the investigation
- Ability and willingness to follow and complete the procedures of the investigation
Who cannot join
- Contraindications to the axillary block (e.g., local infection)
- Refusal of locoregional anesthesia for the surgical procedure
- Pre-existing neurologic deficits in the operative extremity
- Body Mass Index ≥ 35 kg/m2
- Known allergy to local anesthetic (mepicavaine hydrochloride)
- Inability to comply with post-operative evaluations e.g. due to language problems, psychological disorders, dementia, etc. of the subject
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Ospedale Regionale di Bellinzona e Valli, EOC
Bellinzona
About this study
Official title: A Single-Center, First-in-Human, Randomized, Controlled, Feasibility Study of a New Device for the Real-Time Continuous Monitoring of the Injection Pressure of Local Anesthetic in Subjects Undergoing Ultrasound-guided Peripheral Nerve Block: the Smart Needle Monitoring System Investigation
The goal of this clinical trial with medical device is to learn if the Smart Needle Monitoring System works to maintain a safe low injection pressure during a type of regional anaesthetic (Peripheral Nerve Block (PNB)) in patients due to undergo surgery below the elbow . It will also learn about the safety of the device and patients' perception of the quality of anesthesia.
Participants will:
- be operated locally according to standard clinical practice
- undergo post-anesthesia recovery and any neurologic symptoms or signs assessment on postoperative days 1 and 7
- Conditions
- No Condition, Real-time Monitoring of the Injection Pressure During Ultrasound-guided Axillary Block
- Being tested
- Smart Needle Monitoring System
- Keywords
- axillary block, injection pressure, real-time monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Needle Monitoring SystemDevice
The Smart Needle Monitoring System is used to perform the ultrasound-guided axillary block. The monitor connected to the Smart Needle will display real-time and record the injection pressure profile during the entire PNB procedure
| Study group | Role | What they receive |
|---|---|---|
| Smart Needle displaying | Experimental | The Smart Needle Monitoring System is used to perform the ultrasound-guided axillary block. The monitor connected to the Smart Needle will display real-time and record the injection pressure profile during the entire PNB procedure.
The anesthesiologist will use the real-time visual feedback to maintain a low injection pressure profile (i.e., not higher than 15 psi) and avoid pressure peaks. The anesthesiologist can immediately stop the injection if there is a sudden increase in pressure, reposition the needle and start again, while always maintaining a low injection pressure profile Receives: Device: Smart Needle Monitoring System |
| Smart Needle flipped | Other | The Smart Needle Monitoring System is used to perform the ultrasound-guided axillary block. The monitor connected to the Smart Needle will be flipped allowing the recording of the injection pressure but not the real-time visualization by the anesthesiologist, who will perform the procedure as usual without a pressure visual feedback Receives: Device: Smart Needle Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of injected nerves with at least one injection pressure peak in the investigational group compared to the standard (control) group
The proportion of injected nerves with at least one injection pressure peak in the investigational group compared to the standard (control) group. A peak is defined as an injection pressure reaching a value above the threshold of 15 psi
Measured: Perioperative
Secondary outcomes (4)
Success of the block
Success of the block is defined as no conversion to general anesthesia (avoidance of rescue block, etc.)
Measured: Perioperative
Number of times of needle tip repositioning
Number of times of needle tip repositioning, defined as the need to stop the ultrasound- guided PNB procedure to avoid excessive high pressure and reposition the needle tip
Measured: Perioperative
Total number of injection pressure peaks
Total number of injection pressure peaks, i.e. raises of the injection pressure above the threshold of 15 psi, for each injected nerve
Measured: Perioperative
Quality of anesthesia from a patient's perspective
Interview to the patient with 8 questions about quality of anesthesia from a patient's perspective in terms of pain, perception of needle movements and discomfort during the anesthesia procedure, and overall satisfaction; both Closed-ended questions and questions with scores 0 (worst) to 10 (best)
Measured: postoperative, 1 and 7 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start19 Dec 2025
- Primary completion14 Aug 2026
- Study completion14 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No ConditionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dossi Roberto, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302997
- Sponsor's protocol ID
- 2025-D0048
- Acronym
- Smart Needle
- Status last verified
- Oct 2026
- First submitted
- 27 Nov 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, First-in-Human, Randomized, Controlled, Feasibility Study of a New Device for the Real-Time Continuous Monitoring of the Injection Pressure of Local Anesthetic in Subjects Undergoing Ultrasound-guided Peripheral Nerve Block: the Smart Needle Monitoring System Investigation
- ClinicalTrials.gov ID
- NCT07302997
- Acronym / sponsor ID
- Smart Needle / 2025-D0048
- Conditions
- No Condition, Real-time Monitoring of the Injection Pressure During Ultrasound-guided Axillary Block
- Keywords
- axillary block, injection pressure, real-time monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 14 Aug 2026 (actual)
- Study completion
- 14 Aug 2026 (actual)
- First posted
- 24 Dec 2025 (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 goal of this clinical trial with medical device is to learn if the Smart Needle Monitoring System works to maintain a safe low injection pressure during a type of regional anaesthetic (Peripheral Nerve Block (PNB)) in patients due to undergo surgery below the elbow . It will also learn about the safety of the device and patients' perception of the quality of anesthesia.
Participants will:
- be operated locally according to standard clinical practice
- undergo post-anesthesia recovery and any neurologic symptoms or signs assessment on postoperative days 1 and 7
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart Needle displaying | Experimental | Device: Smart Needle Monitoring SystemThe Smart Needle Monitoring System is used to perform the ultrasound-guided axillary block. The monitor connected to the Smart Needle will display real-time and record the injection pressure profile during the entire PNB procedure. The anesthesiologist will use the real-time visual feedback to maintain a low injection pressure profile (i.e., not higher than 15 psi) and avoid pressure peaks. The anesthesiologist can immediately stop the injection if there is a sudden increase in pressure, reposition the needle and start again, while always maintaining a low injection pressure profile |
| Smart Needle flipped | Other | Device: Smart Needle Monitoring SystemThe Smart Needle Monitoring System is used to perform the ultrasound-guided axillary block. The monitor connected to the Smart Needle will be flipped allowing the recording of the injection pressure but not the real-time visualization by the anesthesiologist, who will perform the procedure as usual without a pressure visual feedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed Consent signed by the subject
- Age ≥ 18 years
- Scheduled for elective surgery below the elbow (e.g., hand surgery, distal radius surgery, forearm surgery) requiring an axillary block
- ASA physical status I-III
- Ability to understand the investigation
Key exclusion criteria (6 listed)
- Contraindications to the axillary block (e.g., local infection)
- Refusal of locoregional anesthesia for the surgical procedure
- Pre-existing neurologic deficits in the operative extremity
- Body Mass Index ≥ 35 kg/m2
- Known allergy to local anesthetic (mepicavaine hydrochloride)
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 |
|---|---|---|
| Smart Needle Monitoring SystemThe Smart Needle Monitoring System is used to perform the ultrasound-guided axillary block. The monitor connected to the Smart Needle will display real-time and record the injection pressure profile during the entire PNB procedure | Device | Smart Needle displaying, Smart Needle flipped |
Primary outcome
proportion of injected nerves with at least one injection pressure peak in the investigational group compared to the standard (control) group
Time frame: Perioperative
The proportion of injected nerves with at least one injection pressure peak in the investigational group compared to the standard (control) group. A peak is defined as an injection pressure reaching a value above the threshold of 15 psi
4 secondary outcomes
Success of the block
Time frame: Perioperative
Number of times of needle tip repositioning
Time frame: Perioperative
Total number of injection pressure peaks
Time frame: Perioperative
Quality of anesthesia from a patient's perspective
Time frame: postoperative, 1 and 7 days after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Smart Needle Monitoring System in people with No Condition and Real-time Monitoring of the Injection Pressure During Ultrasound-guided Axillary Block, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 23 Oct 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
proportion of injected nerves with at least one injection pressure peak in the investigational group compared to the standard (control) group (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2026.