ErgonomicsNCT07140835
Evaluation of the Pedal-Controlled Surgistep Platform to Improve Ergonomics
A study testing SurgiStep Platform and Standard Foot stool in people with Ergonomics, run by Stanford University at 1 site in United States.
Trial summary
Primary Aim: Assess improvement in ergonomics and musculoskeletal discomfort with the Surgistep compared to a standard footstool. Read more about this study
- Who is it for?
- Ages 36 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ergonomics
- What is being tested?
- SurgiStep Platform and Standard Foot stool
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2025to Nov 2025
- 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 36 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Regularly perform neurosurgical procedures (cranial/spine)
- Willing to use both devices (multiple times each).
Who cannot join
- Severe MSK conditions preventing device usage
- Inability/refusal to participate in observation or surveys.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Crossover Study Evaluating the Pedal-Controlled Surgistep Platform to Improve Ergonomics in Neurosurgical Operations
Primary Aim: Assess improvement in ergonomics and musculoskeletal discomfort with the Surgistep compared to a standard footstool.
- Conditions
- Ergonomics
- Being tested
- SurgiStep Platform, Standard Foot stool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgiStep PlatformDevice
The Surgistep (pedal-controlled, adjustable platform) allows real-time height adjustment during surgery. The surgeons can adjust the height of the platform.
Standard Foot stoolDevice
Foot stool is considered as the standard of care during surgery.
| Study group | Role | What they receive |
|---|---|---|
| SurgiStep Platform | Experimental | The surgeon will be performing the surgery by standing over the SurgiStep Platform. The duration of the usage depends on the length of the surgery being performed by the surgeon. Surgeons will be using this platform for 2 weeks, after which they will be operating on standard foot stool for 2 weeks. Receives: Device: SurgiStep Platform; Device: Standard Foot stool |
| Standard surgical practice | Placebo comparator | The surgeon will be performing the surgery by standing over the standard of care (foot stool). The duration of the usage depends on the length of the surgery being performed by the surgeon. Surgeons use standard foot stool for 2 weeks, and switch to SurgiStep platform for 2 weeks. Receives: Device: SurgiStep Platform; Device: Standard Foot stool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid Entire Body Assessment (REBA) Scale Score
The REBA (Rapid Entire Body Assessment) score, used to assess the risk of musculoskeletal disorders (MSDs) in work tasks, ranges from 1 to 15. A lower REBA score indicates a lower risk, with scores below 4 considered to have minimal risk. Higher scores indicate increased risk, with scores of 8 or more indicating a high risk that requires immediate attention and intervention
Measured: During the surgery upto 60 minutes
Rapid Upper Limb Assessment (RULA) Scale Score
The RULA (Rapid Upper Limb Assessment) scale ranges from 1 to 7, with lower scores indicating lower risk and higher scores indicating higher risk of musculoskeletal disorders.
Measured: During the surgery upto 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErgonomicsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atman Desai, Stanford University
- Investigators
- Atman Desai, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140835
- Sponsor's protocol ID
- 80476
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Crossover Study Evaluating the Pedal-Controlled Surgistep Platform to Improve Ergonomics in Neurosurgical Operations
- ClinicalTrials.gov ID
- NCT07140835
- Acronym / sponsor ID
- 80476
- Conditions
- Ergonomics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 26 Aug 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.
Primary Aim: Assess improvement in ergonomics and musculoskeletal discomfort with the Surgistep compared to a standard footstool.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SurgiStep Platform | Experimental | Device: SurgiStep Platform, Device: Standard Foot stoolThe surgeon will be performing the surgery by standing over the SurgiStep Platform. The duration of the usage depends on the length of the surgery being performed by the surgeon. Surgeons will be using this platform for 2 weeks, after which they will be operating on standard foot stool for 2 weeks. |
| Standard surgical practice | Placebo comparator | Device: SurgiStep Platform, Device: Standard Foot stoolThe surgeon will be performing the surgery by standing over the standard of care (foot stool). The duration of the usage depends on the length of the surgery being performed by the surgeon. Surgeons use standard foot stool for 2 weeks, and switch to SurgiStep platform for 2 weeks. |
Who may qualify
- Ages
- 36 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Regularly perform neurosurgical procedures (cranial/spine)
- Willing to use both devices (multiple times each).
Key exclusion criteria (2 listed)
- Severe MSK conditions preventing device usage
- Inability/refusal to participate in observation or surveys.
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 |
|---|---|---|
| SurgiStep PlatformThe Surgistep (pedal-controlled, adjustable platform) allows real-time height adjustment during surgery. The surgeons can adjust the height of the platform. | Device | Standard surgical practice, SurgiStep Platform |
| Standard Foot stoolFoot stool is considered as the standard of care during surgery. | Device | Standard surgical practice, SurgiStep Platform |
Primary outcome
Rapid Entire Body Assessment (REBA) Scale Score
Time frame: During the surgery upto 60 minutes
The REBA (Rapid Entire Body Assessment) score, used to assess the risk of musculoskeletal disorders (MSDs) in work tasks, ranges from 1 to 15. A lower REBA score indicates a lower risk, with scores below 4 considered to have minimal risk. Higher scores indicate increased risk, with scores of 8 or more indicating a high risk that requires immediate attention and intervention
Rapid Upper Limb Assessment (RULA) Scale Score
Time frame: During the surgery upto 60 minutes
The RULA (Rapid Upper Limb Assessment) scale ranges from 1 to 7, with lower scores indicating lower risk and higher scores indicating higher risk of musculoskeletal disorders.
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 26 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Atman Desai, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SurgiStep Platform and Standard Foot stool in people with Ergonomics, run by Stanford University 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 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: opening soon, as of the sponsor's last update on 26 Aug 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. Some participants in this study may receive a placebo. 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?
Rapid Entire Body Assessment (REBA) Scale Score (time frame: During the surgery upto 60 minutes). 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?
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 Aug 2025.