Spinal DiseasesNCT07171801
Comparing 3D and 2D Views in Biportal Spine Surgery: A Pilot Simulation Study
A study testing Three-Dimensional Endoscopic Visualization and Two-Dimensional Endoscopic Visualization in people with Spinal Diseases and Endoscopy Simulation, run by Felix Corr.
Trial summary
This study aims to compare three-dimensional (3D) and two-dimensional (2D) visualization in biportal endoscopic spine surgery using a simulated environment. Surgeons will perform standardized tasks on a spine model while using either 3D or 2D endoscopic systems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Diseases, Endoscopy Simulation, Lumbar Vertebrae
- What is being tested?
- Three-Dimensional Endoscopic Visualization and Two-Dimensional Endoscopic Visualization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Enrolled in the neurosurgical residency or fellowship program at the Department of Neurosurgery, Cantonal Hospital of St. Gallen, Switzerland
- Completion of basic neurosurgical training modules, including introductory endoscopic handling
- Age ≥ 18 years
- Willingness and ability to provide informed consent
Who cannot join
- Prior substantial experience with three-dimensional (3D) endoscopy (defined as > 5 independent procedures performed with 3D visualization systems)
- Ocular or neurological conditions impairing stereopsis, fine motor control, or safe endoscope handling
- Inability or unwillingness to complete the simulation protocol
- Declined participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 3D vs. 2D Unilateral Biportal Endoscopic Spine Surgery: A Randomized Blinded Crossover Pilot Simulation Study
This study aims to compare three-dimensional (3D) and two-dimensional (2D) visualization in biportal endoscopic spine surgery using a simulated environment. Surgeons will perform standardized tasks on a spine model while using either 3D or 2D endoscopic systems. The goal is to determine whether 3D technology can improve precision, efficiency, and movement control during surgery. The study uses a randomized, blinded, crossover design to ensure objective results and may help guide future training and technology use in spinal endoscopy.
Read the detailed description
Spinal endoscopy, particularly the unilateral biportal endoscopic (UBE) technique, is an increasingly adopted minimally invasive approach for treating lumbar spine pathologies. While it offers clinical advantages over traditional open surgery-including less tissue disruption, reduced blood loss, and faster recovery-its uptake has been limited, in part due to the technical challenges associated with two-dimensional (2D) endoscopic visualization. The lack of depth perception inherent to 2D imaging can impair spatial orientation, hand-eye coordination, and surgical precision, especially in anatomically complex regions such as the lumbar spine.
Three-dimensional (3D) endoscopic systems are designed to address this limitation by restoring binocular depth cues and providing stereoscopic visualization. Preliminary evidence from other surgical fields-such as laparoscopy and cranial neurosurgery-suggests that 3D visualization improves operative performance, task efficiency, and user confidence. However, the benefits of 3D visualization in spinal endoscopy remain poorly understood, with no rigorous controlled studies to date assessing its impact on performance metrics under standardized conditions.
This randomized, blinded, crossover pilot study is designed to objectively evaluate the effect of 3D versus 2D endoscopic visualization on technical performance during simulated UBE procedures. Participants-including surgeons at various experience levels-will complete standardized surgical tasks on high-fidelity lumbar spine models using both 2D and 3D endoscopic systems. Motion tracking technology will be employed to quantitatively analyze instrument movement, capturing key metrics such as path length, velocity, motion economy, and high-velocity excursions.
The crossover design ensures that each participant serves as their own control, and blinding minimizes observational bias during performance assessment. The simulation setting allows for reproducible conditions free from patient-related variability, ensuring that observed differences can be attributed to visualization modality rather than anatomical or clinical complexity.
Findings from this study will provide foundational data on the potential utility of 3D visualization in spinal endoscopy, with implications for surgical training, operative safety, and the future integration of stereoscopic technologies in spine surgery.
- Conditions
- Spinal Diseases, Endoscopy Simulation, Lumbar Vertebrae, Randomized Controlled Trial, Three-Dimensional, Simulation Training
- Being tested
- Three-Dimensional Endoscopic Visualization, Two-Dimensional Endoscopic Visualization
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-Dimensional Endoscopic VisualizationDevice
Use of a stereoscopic 3D high-definition endoscopic system with dual optical channels, projecting to a stereoscopic monitor viewed with polarized glasses, to perform standardized spinal simulation tasks.
Two-Dimensional Endoscopic VisualizationDevice
Use of the same high-definition endoscopic system with stereoscopic function deactivated, providing conventional monoscopic two-dimensional visualization, to perform standardized spinal simulation tasks.
| Study group | Role | What they receive |
|---|---|---|
| Three-Dimensional Endoscopy First, Then Two-Dimensional | Other | Participants first perform standardized spinal endoscopic simulation tasks using a stereoscopic three-dimensional (3D) endoscopic system providing binocular depth perception via dual optical channels and polarized glasses. After completing all tasks under 3D visualization, the same participants subsequently repeat the identical tasks using conventional two-dimensional (2D) visualization on the same high-definition endoscopic platform Receives: Device: Three-Dimensional Endoscopic Visualization; Device: Two-Dimensional Endoscopic Visualization |
| Two-Dimensional Endoscopy First, Then Three-Dimensional | Other | Participants first perform standardized spinal endoscopic simulation tasks using conventional two-dimensional (2D) visualization, with stereoscopic capability deactivated, displaying a monoscopic high-definition image. After completing all tasks under 2D visualization, the same participants subsequently repeat the identical tasks using stereoscopic three-dimensional (3D) visualization on the same endoscopic platform, viewed with polarized glasses. Receives: Device: Three-Dimensional Endoscopic Visualization; Device: Two-Dimensional Endoscopic Visualization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Task Completion Time (seconds) and Error Rate During Spinal Endoscopic Simulation, Assessed Immediately Post-Task
Task performance was assessed during standardized spinal endoscopic simulation tasks under both three-dimensional (3D) and two-dimensional (2D) visualization. Task completion time was measured in seconds with a digital stopwatch from the start to the successful completion of each task. Task accuracy was assessed as the number of predefined errors, including deviations from the optimal trajectory or inadvertent contact with marked "no-go" zones on the simulation model. Both measures were collected immediately during each simulation session. Lower times and fewer errors indicate better performance.
Measured: Immediately during each simulation session (within minutes of task performance).
Difference in Task Completion Time (seconds) and Error Rate During Spinal Endoscopic Simulation, Assessed Immediately Post-Task
Task performance was assessed during standardized spinal endoscopic simulation tasks under both three-dimensional (3D) and two-dimensional (2D) visualization. Task completion time was measured in seconds with a digital stopwatch from the start to the successful completion of each task. Task accuracy was assessed as the number of predefined errors, including deviations from the optimal trajectory or inadvertent contact with marked "no-go" zones on the simulation model. Both measures were collected immediately during each simulation session. Lower times and fewer errors indicate better performanc
Measured: Immediately during each simulation session (within minutes of task performance).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal DiseasesStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study employs a randomized, single-center, blinded, crossover design in a high-fidelity simulated surgical environment. Each participant performs standardized unilateral biportal endoscopic spine surgery tasks using both 2D and 3D visualization systems in a randomized sequence. A washout period is incorporated between conditions to minimize carryover effects. This within-subjects crossover model allows each participant to serve as their own control, increasing statistical power and reducing inter-individual variability. Blinding is maintained for performance assessors, and objective motion tracking metrics are used to evaluate technical performance under each visualization condition.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Felix Corr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Felix Corr, Cantonal Hospital of St. Gallen
- Investigators
- Stefan Motov, MD, Principal investigator, Kantonsspital St. Gallen, Health Ostschweiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171801
- Sponsor's protocol ID
- V1
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study generated only simulation performance and questionnaire data from healthy volunteer trainees. No clinical or patient-level data were collected. Individual-level data will not be shared, but summary results are available in the publication.
Publications
Ban Y, Mcneely B, Chadha NK, Felton M. Safety and efficacy of three-dimensional versus two-dimensional endoscopy in otolaryngology surgery and training: A systematic review. Clin Otolaryngol. 2024 Sep;49(5):538-551. doi: 10.1111/coa.14171. Epub 2024 May 12.
PubMed 38735751Heo DH, Kim JY, Park JY, Kim JS, Kim HS, Roh J, Park CK, Chung H. Clinical Experiences of 3-Dimensional Biportal Endoscopic Spine Surgery for Lumbar Degenerative Disease. Oper Neurosurg. 2022 Apr 1;22(4):231-238. doi: 10.1227/ONS.0000000000000090.
PubMed 35147593Ma A, Xie N, Reidy J, Mobbs RJ. Three-dimensional endoscopy in lumbar spine surgery as a novel approach for degenerative pathologies: a case report. J Surg Case Rep. 2024 Aug 28;2024(8):rjae540. doi: 10.1093/jscr/rjae540. eCollection 2024 Aug.
PubMed 39211372
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D vs. 2D Unilateral Biportal Endoscopic Spine Surgery: A Randomized Blinded Crossover Pilot Simulation Study
- ClinicalTrials.gov ID
- NCT07171801
- Acronym / sponsor ID
- V1
- Conditions
- Spinal Diseases, Endoscopy Simulation, Lumbar Vertebrae, Randomized Controlled Trial, Three-Dimensional, Simulation Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Felix CorrUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 15 Sep 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.
This study aims to compare three-dimensional (3D) and two-dimensional (2D) visualization in biportal endoscopic spine surgery using a simulated environment. Surgeons will perform standardized tasks on a spine model while using either 3D or 2D endoscopic systems. The goal is to determine whether 3D technology can improve precision, efficiency, and movement control during surgery. The study uses a randomized, blinded, crossover design to ensure objective results and may help guide future training and technology use in spinal endoscopy.
Detailed description
Spinal endoscopy, particularly the unilateral biportal endoscopic (UBE) technique, is an increasingly adopted minimally invasive approach for treating lumbar spine pathologies. While it offers clinical advantages over traditional open surgery-including less tissue disruption, reduced blood loss, and faster recovery-its uptake has been limited, in part due to the technical challenges associated with two-dimensional (2D) endoscopic visualization. The lack of depth perception inherent to 2D imaging can impair spatial orientation, hand-eye coordination, and surgical precision, especially in anatomically complex regions such as the lumbar spine.
Three-dimensional (3D) endoscopic systems are designed to address this limitation by restoring binocular depth cues and providing stereoscopic visualization. Preliminary evidence from other surgical fields-such as laparoscopy and cranial neurosurgery-suggests that 3D visualization improves operative performance, task efficiency, and user confidence. However, the benefits of 3D visualization in spinal endoscopy remain poorly understood, with no rigorous controlled studies to date assessing its impact on performance metrics under standardized conditions.
This randomized, blinded, crossover pilot study is designed to objectively evaluate the effect of 3D versus 2D endoscopic visualization on technical performance during simulated UBE procedures. Participants-including surgeons at various experience levels-will complete standardized surgical tasks on high-fidelity lumbar spine models using both 2D and 3D endoscopic systems. Motion tracking technology will be employed to quantitatively analyze instrument movement, capturing key metrics such as path length, velocity, motion economy, and high-velocity excursions.
The crossover design ensures that each participant serves as their own control, and blinding minimizes observational bias during performance assessment. The simulation setting allows for reproducible conditions free from patient-related variability, ensuring that observed differences can be attributed to visualization modality rather than anatomical or clinical complexity.
Findings from this study will provide foundational data on the potential utility of 3D visualization in spinal endoscopy, with implications for surgical training, operative safety, and the future integration of stereoscopic technologies in spine surgery.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study employs a randomized, single-center, blinded, crossover design in a high-fidelity simulated surgical environment. Each participant performs standardized unilateral biportal endoscopic spine surgery tasks using both 2D and 3D visualization systems in a randomized sequence. A washout period is incorporated between conditions to minimize carryover effects. This within-subjects crossover model allows each participant to serve as their own control, increasing statistical power and reducing inter-individual variability. Blinding is maintained for performance assessors, and objective motion tracking metrics are used to evaluate technical performance under each visualization condition.
| Arm | Type | Receives |
|---|---|---|
| Three-Dimensional Endoscopy First, Then Two-Dimensional | Other | Device: Three-Dimensional Endoscopic Visualization, Device: Two-Dimensional Endoscopic VisualizationParticipants first perform standardized spinal endoscopic simulation tasks using a stereoscopic three-dimensional (3D) endoscopic system providing binocular depth perception via dual optical channels and polarized glasses. After completing all tasks under 3D visualization, the same participants subsequently repeat the identical tasks using conventional two-dimensional (2D) visualization on the same high-definition endoscopic platform |
| Two-Dimensional Endoscopy First, Then Three-Dimensional | Other | Device: Three-Dimensional Endoscopic Visualization, Device: Two-Dimensional Endoscopic VisualizationParticipants first perform standardized spinal endoscopic simulation tasks using conventional two-dimensional (2D) visualization, with stereoscopic capability deactivated, displaying a monoscopic high-definition image. After completing all tasks under 2D visualization, the same participants subsequently repeat the identical tasks using stereoscopic three-dimensional (3D) visualization on the same endoscopic platform, viewed with polarized glasses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Enrolled in the neurosurgical residency or fellowship program at the Department of Neurosurgery, Cantonal Hospital of St. Gallen, Switzerland
- Completion of basic neurosurgical training modules, including introductory endoscopic handling
- Age ≥ 18 years
- Willingness and ability to provide informed consent
Key exclusion criteria (4 listed)
- Prior substantial experience with three-dimensional (3D) endoscopy (defined as > 5 independent procedures performed with 3D visualization systems)
- Ocular or neurological conditions impairing stereopsis, fine motor control, or safe endoscope handling
- Inability or unwillingness to complete the simulation protocol
- Declined participation
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 |
|---|---|---|
| Three-Dimensional Endoscopic VisualizationUse of a stereoscopic 3D high-definition endoscopic system with dual optical channels, projecting to a stereoscopic monitor viewed with polarized glasses, to perform standardized spinal simulation tasks. | Device | Three-Dimensional Endoscopy First, Then Two-Dimensional, Two-Dimensional Endoscopy First, Then Three-Dimensional |
| Two-Dimensional Endoscopic VisualizationUse of the same high-definition endoscopic system with stereoscopic function deactivated, providing conventional monoscopic two-dimensional visualization, to perform standardized spinal simulation tasks. | Device | Three-Dimensional Endoscopy First, Then Two-Dimensional, Two-Dimensional Endoscopy First, Then Three-Dimensional |
Primary outcome
Difference in Task Completion Time (seconds) and Error Rate During Spinal Endoscopic Simulation, Assessed Immediately Post-Task
Time frame: Immediately during each simulation session (within minutes of task performance).
Task performance was assessed during standardized spinal endoscopic simulation tasks under both three-dimensional (3D) and two-dimensional (2D) visualization. Task completion time was measured in seconds with a digital stopwatch from the start to the successful completion of each task. Task accuracy was assessed as the number of predefined errors, including deviations from the optimal trajectory or inadvertent contact with marked "no-go" zones on the simulation model. Both measures were collected immediately during each simulation session. Lower times and fewer errors indicate better performance.
Difference in Task Completion Time (seconds) and Error Rate During Spinal Endoscopic Simulation, Assessed Immediately Post-Task
Time frame: Immediately during each simulation session (within minutes of task performance).
Task performance was assessed during standardized spinal endoscopic simulation tasks under both three-dimensional (3D) and two-dimensional (2D) visualization. Task completion time was measured in seconds with a digital stopwatch from the start to the successful completion of each task. Task accuracy was assessed as the number of predefined errors, including deviations from the optimal trajectory or inadvertent contact with marked "no-go" zones on the simulation model. Both measures were collected immediately during each simulation session. Lower times and fewer errors indicate better performanc
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 16 Sep 2025.
- Results publication: PubMed 38735751Ban Y, Mcneely B, Chadha NK, Felton M. Safety and efficacy of three-dimensional versus two-dimensional endoscopy in otolaryngology surgery and training: A systematic review. Clin Otolaryngol. 2024 Sep;49(5):538-551. doi: 10.1111/coa.14171. Epub 2024 May 12.
- Results publication: PubMed 35147593Heo DH, Kim JY, Park JY, Kim JS, Kim HS, Roh J, Park CK, Chung H. Clinical Experiences of 3-Dimensional Biportal Endoscopic Spine Surgery for Lumbar Degenerative Disease. Oper Neurosurg. 2022 Apr 1;22(4):231-238. doi: 10.1227/ONS.0000000000000090.
- Results publication: PubMed 39211372Ma A, Xie N, Reidy J, Mobbs RJ. Three-dimensional endoscopy in lumbar spine surgery as a novel approach for degenerative pathologies: a case report. J Surg Case Rep. 2024 Aug 28;2024(8):rjae540. doi: 10.1093/jscr/rjae540. eCollection 2024 Aug.
- Individual participant dataSharing planned: No. The study generated only simulation performance and questionnaire data from healthy volunteer trainees. No clinical or patient-level data were collected. Individual-level data will not be shared, but summary results are available in the publication.
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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.
Stefan Motov, MD principal investigator
Kantonsspital St. Gallen, Health Ostschweiz
Questions about this trial
What is this clinical trial studying?
A study testing Three-Dimensional Endoscopic Visualization and Two-Dimensional Endoscopic Visualization in people with Spinal Diseases and Endoscopy Simulation, run by Felix Corr.
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 4 inclusion and 4 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 16 Sep 2025. 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?
Contact Felix Corr, MD, MSc. (+41 71 494 1636, felix.corr@h-och.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Task Completion Time (seconds) and Error Rate During Spinal Endoscopic Simulation, Assessed Immediately Post-Task (time frame: Immediately during each simulation session (within minutes of task performance).). 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?
On the ClinicalTrials.gov record for NCT07171801, which also lists 3 linked publications.
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 16 Sep 2025.