Robotic SurgeryNCT06146023
Performance of Robotic Microsurgery Systems
A study testing Robotic anastomosis (Symani surgical system and RoboticScope) and Conventional anastomosis in people with Robotic Surgery and Microsurgery, run by University Hospital Muenster at 2 sites in 2 countries.
Trial summary
The goal of this preclinical trial is to learn about the benefits and limitations of novel robotic devices for microsurgery, based on different levels of microsurgical experience. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Robotic Surgery, Microsurgery, Anastomosis
- What is being tested?
- Robotic anastomosis (Symani surgical system and RoboticScope) and Conventional anastomosis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2022to 1 Jul 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Novices: no prior experience in microsurgery
- Residents: 2-4 years of experience in microsurgery
- Experts: at least 5 years of experience in microsurgery
Who cannot join
- previous training with the robotic devices applied in this study
- contraindications for usage of robotic devices (magnetic field)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: Preclinical Performance of The Combined Application of Two Robotic Systems in Microsurgery
The goal of this preclinical trial is to learn about the benefits and limitations of novel robotic devices for microsurgery, based on different levels of microsurgical experience. The main questions it aims to answer are:
Is robot-assisted microsurgery faster, better and more ergonomic than conventional microsurgery in a preclinical standardized setting?
Participants will perform microvascular anastomoses on 1.0-mm-diameter artificial silicone vessels using a conventional manual approach versus a novel robot-assisted approach. Researchers will compare the performance of novices, advanced participants and experts to evaluate the role of microsurgical experience when learning the new technique.
Read the detailed description
Recent advancements in the development of robotic devices increasingly draw the attention towards the concept of robotic microsurgery, as several systems tailored to open microsurgery are being introduced. This study describes the combined application of a novel microsurgical robot, the Symani, with a novel robotic microscope, the RoboticScope, for the performance of microvascular anastomoses in a two-center preclinical trial.
- Conditions
- Robotic Surgery, Microsurgery, Anastomosis
- Being tested
- Robotic anastomosis (Symani surgical system and RoboticScope), Conventional anastomosis
- Keywords
- Learning curve, Robotics, Surgical ergonomics, Surgical training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic anastomosis (Symani surgical system and RoboticScope)Device
Robot-assisted microvascular anastomosis on 1.0-mm-diameter silicone vessels using the Symani surgical system and RoboticScope
Conventional anastomosisProcedure or surgery
Conventional microvascular anastomosis on 1.0-mm-diameter silicone vessels using conventional microsurgical instruments and conventional surgical microscope
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Conventional microsurgery with conventional microsurgical instruments and conventional surgical microscope Receives: Procedure: Conventional anastomosis |
| Robotic | Experimental | Robot-assisted microsurgery with microsurgery robot and robotic microscope Receives: Device: Robotic anastomosis (Symani surgical system and RoboticScope) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical time
Time to perform anastomosis in minutes and seconds.
Measured: Duration of anastomosis
Anastomosis quality
Anastomosis lapse index (ALI) to evaluate the quality of each stitch. Score indicates absolute number of errors per anastomosis. Low values indicate better results.
Measured: Evaluated right after completion of each anastomosis
Microsurgical skills
Structured assessment of microsurgery skills (SAMS) to evaluate microsurgical skill acquisition. Score includes 8 items evaluated from 1 (minimum) to 5 (maximum). High values indicate better results.
Measured: Duration of anastomosis
Secondary outcomes (2)
Subjective Satisfaction
Satisfaction with anastomosis und robotic performance (Questionnaire). Evaluation of anastomosis and robotic devices from 1 (minimum) to 10 (maximum). High values indicate better results.
Measured: Evaluated right after completion of each anastomosis
Surgical ergonomics
Rapid entire body assessment (REBA) to evaluate surgical ergonomics. Numeric score, low values indicate better results.
Measured: Evaluated right after completion of each anastomosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Oct 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic SurgeryStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of conventional manual microsurgery versus robot-assisted microsurgery
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Principal investigator, Kai Wessel, University Hospital Muenster
- Investigators
- Maximilian Kückelhaus, MD, Principal investigator, University Hospital MuensterHaripriya S Ayyala, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146023
- Sponsor's protocol ID
- 2000034951
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Primary data from this study can be made available upon request for dedicated purposes.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preclinical Performance of The Combined Application of Two Robotic Systems in Microsurgery
- ClinicalTrials.gov ID
- NCT06146023
- Acronym / sponsor ID
- 2000034951
- Conditions
- Robotic Surgery, Microsurgery, Anastomosis
- Keywords
- Learning curve, Robotics, Surgical ergonomics, Surgical training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 24 Nov 2023 (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 preclinical trial is to learn about the benefits and limitations of novel robotic devices for microsurgery, based on different levels of microsurgical experience. The main questions it aims to answer are:
Is robot-assisted microsurgery faster, better and more ergonomic than conventional microsurgery in a preclinical standardized setting?
Participants will perform microvascular anastomoses on 1.0-mm-diameter artificial silicone vessels using a conventional manual approach versus a novel robot-assisted approach. Researchers will compare the performance of novices, advanced participants and experts to evaluate the role of microsurgical experience when learning the new technique.
Detailed description
Recent advancements in the development of robotic devices increasingly draw the attention towards the concept of robotic microsurgery, as several systems tailored to open microsurgery are being introduced. This study describes the combined application of a novel microsurgical robot, the Symani, with a novel robotic microscope, the RoboticScope, for the performance of microvascular anastomoses in a two-center preclinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Comparison of conventional manual microsurgery versus robot-assisted microsurgery
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Procedure: Conventional anastomosisConventional microsurgery with conventional microsurgical instruments and conventional surgical microscope |
| Robotic | Experimental | Device: Robotic anastomosis (Symani surgical system and RoboticScope)Robot-assisted microsurgery with microsurgery robot and robotic microscope |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Novices: no prior experience in microsurgery
- Residents: 2-4 years of experience in microsurgery
- Experts: at least 5 years of experience in microsurgery
Key exclusion criteria (2 listed)
- previous training with the robotic devices applied in this study
- contraindications for usage of robotic devices (magnetic field)
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 |
|---|---|---|
| Robotic anastomosis (Symani surgical system and RoboticScope)Robot-assisted microvascular anastomosis on 1.0-mm-diameter silicone vessels using the Symani surgical system and RoboticScope | Device | Robotic |
| Conventional anastomosisConventional microvascular anastomosis on 1.0-mm-diameter silicone vessels using conventional microsurgical instruments and conventional surgical microscope | Procedure or surgery | Conventional |
Primary outcome
Surgical time
Time frame: Duration of anastomosis
Time to perform anastomosis in minutes and seconds.
Anastomosis quality
Time frame: Evaluated right after completion of each anastomosis
Anastomosis lapse index (ALI) to evaluate the quality of each stitch. Score indicates absolute number of errors per anastomosis. Low values indicate better results.
Microsurgical skills
Time frame: Duration of anastomosis
Structured assessment of microsurgery skills (SAMS) to evaluate microsurgical skill acquisition. Score includes 8 items evaluated from 1 (minimum) to 5 (maximum). High values indicate better results.
2 secondary outcomes
Subjective Satisfaction
Time frame: Evaluated right after completion of each anastomosis
Surgical ergonomics
Time frame: Evaluated right after completion of each anastomosis
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 24 Nov 2023.
- Individual participant dataSharing planned: No. Primary data from this study can be made available upon request for dedicated purposes.
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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.
Maximilian Kückelhaus, MD principal investigator
University Hospital Muenster
Haripriya S Ayyala, MD principal investigator
Yale University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic anastomosis (Symani surgical system and RoboticScope) and Conventional anastomosis in people with Robotic Surgery and Microsurgery, run by University Hospital Muenster at 2 sites in 2 countries.
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 3 inclusion and 2 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 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. 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?
Surgical time (time frame: Duration of anastomosis). 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 24 Nov 2023; AzTrials last refreshed its copy on 27 Oct 2026.