Cranio-spinal Neurosurgical Approaches (Neuro_SURGEM)

December 13, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Cranio-spinal Neurosurgical Approaches: Qualitative and Quantitative Analysis and Validation of New Minimally Invasive Methods on Cadaveric Anatomical Models.

The goal of this observational study is to learn how different cranio-spinal surgical approaches work and how much anatomical exposure each technique provides in donated human cadaver specimens. The study also aims to understand anatomical variations and to evaluate new surgical techniques and tools that may improve neurosurgical training and practice.

The main questions it aims to answer are:

  • How much surgical exposure area and volume of work does each cranio-spinal approach allow?
  • How do anatomical variations influence the effectiveness and feasibility of different approaches? Researchers will also compare results obtained using different surgical visualization methods (such as the surgical microscope approach or macroscopic evaluation) to see if any method improves visibility or operative efficiency.

Cadaveric specimens will undergo:

  • Step-by-step cranio-spinal surgical approaches performed by trained neurosurgeons.
  • Quantitative measurements of exposed anatomical areas using imaging software (BrainChop).
  • Assessment of operative time, perceived difficulty by surgeons, and visibility of target anatomical structures.
  • Testing of new surgical instruments or techniques when applicable, without involving any drugs or medical devices.

This study follows Italian regulations on post-mortem body donation for scientific research (Law No. 10/2020) and is conducted at a single research center recognized as an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico-Scientific Institute for Hospitalization and Care).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This observational, monocentric, preclinical study. The main objective of this study is to conduct a systematic and quantitative preclinical analysis of multiple cranio-spinal surgical approaches, using both macroscopic and microscopic evaluation.

The study evaluates multiple surgical corridors to the cranial and spinal regions and involves detailed measurement of the volume of work and exposed anatomical area attainable with each approach. Additional technical objectives include the analysis of anatomical variations that may influence surgical execution, and the validation of new surgical techniques and instruments in a controlled laboratory environment.

All dissections will be carried out on cadaveric specimens voluntarily donated according to Italian legislation on post-mortem body donation (Law No. 10/2020). Procedures will be performed by trained neurosurgeons using standard microsurgical techniques. Quantitative measurements of exposure areas and operative volumes will be obtained using dedicated imaging software, including BrainChop.

The study also incorporates structured evaluations of technical difficulty and surgeon experience. After completing each approach, operating surgeons will provide standardized ratings of perceived difficulty, visibility of target structures, and usability of any new surgical tools or techniques tested. These assessments contribute to the systematic validation of surgical methods and instrumentation in the preclinical setting.

In addition, the study supports surgical education by integrating structured dissection sessions. Participants (surgeons or trainees) will complete pre- and post-training assessments to evaluate procedural understanding, anatomical knowledge, and perceived skill acquisition.

The study will enroll 35 cadaveric specimens over a three-year period. No drugs or implantable medical devices will be used. All specimens will be stored and handled according to institutional anatomical laboratory standards.

The statistical analysis plan includes descriptive and comparative analyses. Quantitative variables-such as exposure area, volume of work, and operative time-will be summarized as mean ± standard deviation (SD). Qualitative variables-such as visibility scores or difficulty ratings-will be reported as absolute and relative frequencies. For pre- and post-training comparisons, the paired t-test or Wilcoxon signed-rank test will be applied depending on data distribution. Comparisons of operative time or exposure metrics across techniques will be performed using Analysis of Variance (ANOVA) or the Kruskal-Wallis test. Statistical significance will be defined as p < 0.05. All analyses will be conducted using Stata statistical software (StataCorp LLC, College Station, TX, USA).

Study Type

Observational

Enrollment (Estimated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of human cadaveric specimens voluntarily donated for scientific and educational purposes under Italian post-mortem donation regulations. Specimens are obtained through the anatomical donation program of the participating institution and represent a natural range of adult anatomical variability. These cadavers serve as preclinical anatomical models for evaluating cranio-spinal neurosurgical approaches in a controlled laboratory setting. The population provides diverse anatomical characteristics that allow systematic assessment of surgical exposure, feasibility, and technical performance across different surgical corridors.

Description

Inclusion Criteria

  • Cadaveric specimens from individuals who provided informed consent for post-mortem donation of their body or tissues for scientific research.
  • Specimens that meet all legal requirements for anatomical donation under Italian Law No. 10/2020 and Presidential Decree (DPR) No. 47/2023.
  • Specimens that are available for the full duration of the study and suitable for performing multiple cranio-spinal surgical approaches.

Exclusion Criteria

  • Specimens that do not meet the legal or ethical requirements for anatomical donation as defined by Italian regulations.
  • Cadavers with major anatomical deformities, advanced tissue degradation, or pathological conditions that would interfere with surgical dissection or measurement accuracy.
  • Specimens lacking adequate documentation or verified donor consent for post-mortem donation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cranio-Spinal Neurosurgical Approaches Using Cadaveric Specimens
This cohort consists of donated human cadaveric specimens used to evaluate a range of cranio-spinal neurosurgical approaches. The group serves as an anatomical model to study surgical exposure, technical feasibility, and anatomical variation in a controlled preclinical setting. Procedures will involve macroscopic and microscopic visualization methods and may include testing of new surgical techniques or instruments. Surgeons performing the dissections will provide structured assessments of technical difficulty, visibility, and usability of the approaches.
Procedure: Standardized cranio-spinal neurosurgical approaches performed on donated cadaveric specimens to assess surgical exposure, feasibility, anatomical variation, and selected new techniques.
This intervention consists of performing standardized cranio-spinal neurosurgical approaches on donated human cadaveric specimens to evaluate surgical exposure, operative feasibility, and anatomical variation in a preclinical setting. The procedures use both macroscopic and microscopic visualization systems. uantitative measurements of exposure area and operative workspace are obtained through dedicated imaging and navigation-based software. The intervention also allows controlled testing of new surgical tools or techniques, with surgeon-reported assessments of difficulty, visibility, and usability. In addition, hands-on dissection sessions are incorporated to support structured surgical training and technical skill development.
Other Names:
  • No other names or identifiers; refers only to standardized cranio-spinal neurosurgical approaches on cadaveric specimens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of Work Volume and Exposed Area in Cranio-Spinal Surgical Approaches
Time Frame: Measurements will be obtained twice for each approach on every specimen: before the dissection using baseline CT imaging and after completing the approach using repeat CT imaging on the same day.

Work volume represents the three-dimensional operative space created by each cranio-spinal surgical approach. Quantification will be performed using BrainChop imaging software on standardized CT scans. Segmentation will follow predefined protocols to ensure reproducibility. Higher values indicate a larger and more accessible operative corridor.

Unit of Measure: cubic millimeters (mm³).
Measurements will be obtained twice for each approach on every specimen: before the dissection using baseline CT imaging and after completing the approach using repeat CT imaging on the same day.
Exposed Anatomical Surface Area Obtained by Each Surgical Approach
Time Frame: Measurements will be obtained twice for each approach on every specimen: before the dissection using baseline CT imaging and after completing the approach using repeat CT imaging on the same day.

Exposed Anatomical Surface Area Obtained by Each Surgical Approach

Description:

Exposed area corresponds to the two-dimensional anatomical surface revealed by each surgical approach. Measurements will be obtained from CT-based reconstructions using the same standardized segmentation workflow. Higher surface values reflect wider surgical exposure.

Unit of Measure: square millimeter
Measurements will be obtained twice for each approach on every specimen: before the dissection using baseline CT imaging and after completing the approach using repeat CT imaging on the same day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Francesco Doglietto, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 30, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

July 30, 2028

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

December 13, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 7155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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