Anastomosis, SurgicalNCT07427823
Evaluation of MUSA-3 in Microsurgical Anastomoses
A study testing Robot-assisted microsurgical anastomoses in people with Anastomosis, Surgical, run by Microsure.
Trial summary
This study is conducted to evaluate the safety and performance of robot-assisted microsurgical anastomoses with the MUSA-3 system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomosis, Surgical
- What is being tested?
- Robot-assisted microsurgical anastomoses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 28 Sep 2026
- Phase
- Interventional
- 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
Who may be able to join
- Patient age ≥ 18 years.
- Patients requiring procedures involving micro-anastomosis of small anatomical structures-such as blood vessels, nerves, or lymphatic vessels-in free flap, lymphatic, or peripheral nerve surgery.
- Patients who have been selected by the research team at the Clinical Center as appropriate candidates for treatment with MUSA-3 in accordance with the IFU.
- Able to give informed consent before participating in the study.
- Provision of signed and dated informed consent form.
Who cannot join
- Subject participates in a potentially confounding drug or device trial during the course of the study.
- Patients that are pregnant or breastfeeding.
- For Lymphedema patients:
- ≥ISL (International Society of Lymphology) Stage III lymphedema
- History of marcaine or indocyanine green allergy
- Non-viable lymphatic system as determined by ICG lymphatic mapping using near infrared camera
About this study
Official title: Clinical Safety and Performance Evaluation of MUSA-3 in Microsurgical Anastomoses
This study is conducted to evaluate the safety and performance of robot-assisted microsurgical anastomoses with the MUSA-3 system.
- Conditions
- Anastomosis, Surgical
- Being tested
- Robot-assisted microsurgical anastomoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted microsurgical anastomosesDevice
First in human study
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted anastomoses | Experimental | Not described Receives: Device: Robot-assisted microsurgical anastomoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: device-related adverse events (AEs)
Measured: Intraoperatively and through the 30-day post-procedure period
Performance: conversion rate to manual procedure
Measured: Intraoperatively
Clinical performance: vessel patency rate
Measured: Intraoperatively
Secondary outcomes (2)
Anastomosis quality (SAMS score)
The quality of the anastomosis assessed with the Structured Assessment of Microsurgery Skills (SAMS) score.
Measured: Intraoperatively
Anastomosis time
Duration of the full anastomosis from the moment of piercing the vessel wall for the first stitch until the thread of the last stitch is cut.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start20 Apr 2026 (estimated)
- Primary completion28 Sep 2026 (estimated)
- Study completion28 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomosis, SurgicalStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Microsure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427823
- Sponsor's protocol ID
- NL-011051
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety and Performance Evaluation of MUSA-3 in Microsurgical Anastomoses
- ClinicalTrials.gov ID
- NCT07427823
- Acronym / sponsor ID
- NL-011051
- Conditions
- Anastomosis, Surgical
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MicrosureIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 28 Sep 2026 (estimated)
- Study completion
- 28 Sep 2026 (estimated)
- First posted
- 23 Feb 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.
This study is conducted to evaluate the safety and performance of robot-assisted microsurgical anastomoses with the MUSA-3 system.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted anastomoses | Experimental | Device: Robot-assisted microsurgical anastomoses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient age ≥ 18 years.
- Patients requiring procedures involving micro-anastomosis of small anatomical structures-such as blood vessels, nerves, or lymphatic vessels-in free flap, lymphatic, or peripheral nerve surgery.
- Patients who have been selected by the research team at the Clinical Center as appropriate candidates for treatment with MUSA-3 in accordance with the IFU.
- Able to give informed consent before participating in the study.
- Provision of signed and dated informed consent form.
Key exclusion criteria (6 listed)
- Subject participates in a potentially confounding drug or device trial during the course of the study.
- Patients that are pregnant or breastfeeding.
- ≥ISL (International Society of Lymphology) Stage III lymphedema
- History of marcaine or indocyanine green allergy
- Non-viable lymphatic system as determined by ICG lymphatic mapping using near infrared camera
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 |
|---|---|---|
| Robot-assisted microsurgical anastomosesFirst in human study | Device | Robot-assisted anastomoses |
Primary outcome
Safety: device-related adverse events (AEs)
Time frame: Intraoperatively and through the 30-day post-procedure period
Performance: conversion rate to manual procedure
Time frame: Intraoperatively
Clinical performance: vessel patency rate
Time frame: Intraoperatively
2 secondary outcomes
Anastomosis quality (SAMS score)
Time frame: Intraoperatively
Anastomosis time
Time frame: Intraoperatively
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 23 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted microsurgical anastomoses in people with Anastomosis, Surgical, run by Microsure.
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 5 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: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Safety: device-related adverse events (AEs) (time frame: Intraoperatively and through the 30-day post-procedure period). The study lists 3 primary outcomes in all. 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 Feb 2026.