Health Services ResearchNCT06896084
Comparison of Surgeons' Object Discernment Via Their Hands Versus Using a Robotic Surgical System That Does Not Incorporate Haptics
An observational study of Health Services Research, run by Valley Health System at 1 site in United States.
Trial summary
The purpose of this study is to compare surgeons' discernment of 4 balloons filled with different materials when using their eyes and hands versus using the da Vinci robot. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Services Research
- What is being tested?
- da Vinci Xi System
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2023to 9 Aug 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Targeted population are board certifed surgeons and those who are robotic certified surgeons
Who may be able to join
- Board Certified Surgeon
- Robotic Board Certified Surgeon
Who cannot join
- Non Board Certified Surgeon
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare surgeons' discernment of 4 balloons filled with different materials when using their eyes and hands versus using the da Vinci robot.
Read the detailed description
The study design is a non-randomized parallel group study in which a group of surgeons (Group A) will make determinations as to the material within each of four visually identical balloons that contain air, water, petroleum jelly or a firm substance similar to the consistency of a non-ripe banana using their hands and eyes while another group of experienced robotic surgeons (Group B) will do so using the da Vinci Xi System (Intuitive Surgical, Sunnyvale, CA).
Before making their "hands on" determinations as to balloon contents, each participant will be asked to first determine whether they can visually determine the balloon contents without any manipulation. For the purposes of outcome measurement, only two possible outcomes are considered - namely that the 4 balloons are ordered correctly or not.
Investigators will also record each "guess" for all participants in order to report any trends of mis-assortment that may occur.
- Conditions
- Health Services Research
- Being tested
- da Vinci Xi System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
da Vinci Xi SystemDevice
A group of surgeons will make determinations as to the material within identical balloons while using the da Vinci Xi System
| Study group | Role | What they receive |
|---|---|---|
| Group A | Board Certified Surgeons Receives: Device: da Vinci Xi System | |
| Group B | Robotic Board Certified Surgeons Receives: Device: da Vinci Xi System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Farrington-Manning test of Binary Non-Inferiority
Using the Farrington-Manning test of binary non-inferiority, investigators hypothesize that 100% correct balloon discernment by hands-on surgeons and prospectively set 80% correct discernment by robotic surgeons as their definition of non-inferiority. A correct response is a binary outcome for each of the four balloons.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start31 Aug 2023
- Primary completion31 May 2024
- Study completion9 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Services ResearchStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valley Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896084
- Sponsor's protocol ID
- II_Culligan_24JUN23
- Status last verified
- Mar 2025
- First submitted
- 19 Aug 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgeons' Object Discernment Via Their Hands Versus Using a Robotic Surgical System That Does Not Incorporate Haptics
- ClinicalTrials.gov ID
- NCT06896084
- Acronym / sponsor ID
- II_Culligan_24JUN23
- Conditions
- Health Services Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Valley Health SystemUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 9 Aug 2024 (actual)
- First posted
- 26 Mar 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 purpose of this study is to compare surgeons' discernment of 4 balloons filled with different materials when using their eyes and hands versus using the da Vinci robot.
Detailed description
The study design is a non-randomized parallel group study in which a group of surgeons (Group A) will make determinations as to the material within each of four visually identical balloons that contain air, water, petroleum jelly or a firm substance similar to the consistency of a non-ripe banana using their hands and eyes while another group of experienced robotic surgeons (Group B) will do so using the da Vinci Xi System (Intuitive Surgical, Sunnyvale, CA).
Before making their "hands on" determinations as to balloon contents, each participant will be asked to first determine whether they can visually determine the balloon contents without any manipulation. For the purposes of outcome measurement, only two possible outcomes are considered - namely that the 4 balloons are ordered correctly or not.
Investigators will also record each "guess" for all participants in order to report any trends of mis-assortment that may occur.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: da Vinci Xi SystemBoard Certified Surgeons |
| Group B | – | Device: da Vinci Xi SystemRobotic Board Certified Surgeons |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Targeted population are board certifed surgeons and those who are robotic certified surgeons
Key inclusion criteria (2 listed)
- Board Certified Surgeon
- Robotic Board Certified Surgeon
Key exclusion criteria (1 listed)
- Non Board Certified Surgeon
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 |
|---|---|---|
| da Vinci Xi SystemA group of surgeons will make determinations as to the material within identical balloons while using the da Vinci Xi System | Device | Group A, Group B |
Primary outcome
Number of participants with Farrington-Manning test of Binary Non-Inferiority
Time frame: 1 month
Using the Farrington-Manning test of binary non-inferiority, investigators hypothesize that 100% correct balloon discernment by hands-on surgeons and prospectively set 80% correct discernment by robotic surgeons as their definition of non-inferiority. A correct response is a binary outcome for each of the four balloons.
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 26 Mar 2025.
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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 Health Services Research, run by Valley Health System 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 2 inclusion and 1 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 26 Mar 2025. 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?
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?
Number of participants with Farrington-Manning test of Binary Non-Inferiority (time frame: 1 month). 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 26 Mar 2025.