An interventional study of Three-Dimensional Endoscopic Visualization and Two-Dimensional Endoscopic Visualization in Spinal Diseases, Endoscopy Simulation and Lumbar Vertebrae, sponsored by Felix Corr. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by Felix Corr · Not applicable, Interventional, and Device feasibility
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.
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.
174 studies on the registry are indexed under Spinal Diseases; 39 are open to participants now.
This study's planned enrollment of 6 is below the median of 60 across 106 interventional studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →This is the only study on the registry with Felix Corr as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: Three-Dimensional Endoscopic Visualization · Device: Two-Dimensional Endoscopic Visualization
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.
Device: Three-Dimensional Endoscopic Visualization · Device: Two-Dimensional Endoscopic Visualization
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.
Use of the same high-definition endoscopic system with stereoscopic function deactivated, providing conventional monoscopic two-dimensional visualization, to perform standardized spinal simulation tasks.
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.
Time frame: 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
Time frame: Immediately during each simulation session (within minutes of task performance).
No study locations are listed for this record.
Plan to share: 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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