Minimally Invasive TechniquesNeuro_SURGEMNCT07287462
Cranio-spinal Neurosurgical Approaches
An observational study of Minimally Invasive Techniques and Neurosurgical Procedures, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minimally Invasive Techniques, Neurosurgical Procedures, Cadaveric Training
- What is being tested?
- Standardized cranio-spinal neurosurgical approaches performed on donated cadaveric specimens to assess surgical exposure, feasibility, anatomical variation, and selected new techniques.
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 30 Jul 2028
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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: 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:
Read more
- 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).
Read the 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).
- Being tested
- Standardized cranio-spinal neurosurgical approaches performed on donated cadaveric specimens to assess surgical exposure, feasibility, anatomical variation, and selected new techniques.
- Keywords
- Cranio-spinal surgery, Neurosurgery, Minimally invasive techniques, Surgical validation, Anatomical models, Cadaveric dissection, Neuroanatomy, Surgical training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized cranio-spinal neurosurgical approaches performed on donated cadaveric specimens to assess surgical exposure, feasibility, anatomical variation, and selected new techniques.Procedure or surgery
Also called No other names or identifiers; refers only to standardized cranio-spinal neurosurgical approaches on cadaveric specimens
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Standardized cranio-spinal neurosurgical approaches performed on donated cadaveric specimens to assess surgical exposure, feasibility, anatomical variation, and selected new techniques. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of Work Volume and Exposed Area in Cranio-Spinal Surgical Approaches
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).
Measured: 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
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Minimally Invasive TechniquesStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Doglietto, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287462
- Sponsor's protocol ID
- 7155
- Acronym
- Neuro_SURGEM
- Status last verified
- Oct 2025
- First submitted
- 19 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schreiber A, Ferrari M, Rampinelli V, Doglietto F, Belotti F, Lancini D, Ravanelli M, Rodella LF, Fontanella MM, Nicolai P. Modular Endoscopic Medial Maxillectomies: Quantitative Analysis of Surgical Exposure in a Preclinical Setting. World Neurosurg. 2017 Apr;100:44-55. doi: 10.1016/j.wneu.2016.12.094. Epub 2017 Jan 3.
PubMed 28057590Muhanna N, Chan H, Qiu J, Daly M, Khan T, Doglietto F, Kucharczyk W, Goldstein DP, Irish JC, de Almeida JR. Volumetric Analysis of Endoscopic and Maxillary Swing Surgical Approaches for Nasopharyngectomy. J Neurol Surg B Skull Base. 2018 Oct;79(5):466-474. doi: 10.1055/s-0037-1617432. Epub 2018 Jan 19.
PubMed 30210974Jagersberg M, Brodard J, Qiu J, Mansouri A, Doglietto F, Gentili F, Kucharczyk W, Fasel J, Schaller K, Radovanovic I. Quantification of Working Volumes, Exposure, and Target-Specific Maneuverability of the Pterional Craniotomy and Its Minimally Invasive Variants. World Neurosurg. 2017 May;101:710-717.e2. doi: 10.1016/j.wneu.2017.02.011. Epub 2017 Feb 22.
PubMed 28254536Ferrari M, Schreiber A, Mattavelli D, Lombardi D, Rampinelli V, Doglietto F, Rodella LF, Nicolai P. Surgical anatomy of the parapharyngeal space: Multiperspective, quantification-based study. Head Neck. 2019 Mar;41(3):642-656. doi: 10.1002/hed.25378. Epub 2018 Dec 28.
PubMed 30592348Ebner FH, Koerbel A, Kirschniak A, Roser F, Kaminsky J, Tatagiba M. Endoscope-assisted retrosigmoid intradural suprameatal approach to the middle fossa: anatomical and surgical considerations. Eur J Surg Oncol. 2007 Feb;33(1):109-13. doi: 10.1016/j.ejso.2006.09.036. Epub 2006 Nov 14.
PubMed 17110074Doglietto F, Belotti F, Qiu J, Roca E, Radovanovic I, Agur A, Kucharczyk W, Schreiber A, Villaret AB, Nicolai P, Gentili F, Fontanella MM. Endonasal and Transoral Approaches to the Craniovertebral Junction: A Quantitative Anatomical Study. Acta Neurochir Suppl. 2019;125:37-44. doi: 10.1007/978-3-319-62515-7_6.
PubMed 30610300Doglietto F, Qiu J, Ravichandiran M, Radovanovic I, Belotti F, Agur A, Zadeh G, Fontanella MM, Kucharczyk W, Gentili F. Quantitative comparison of cranial approaches in the anatomy laboratory: A neuronavigation based research method. World J Methodol. 2017 Dec 26;7(4):139-147. doi: 10.5662/wjm.v7.i4.139. eCollection 2017 Dec 26.
PubMed 29354486Agosti E, De Maria L, Mattogno PP, Della Pepa GM, D'Onofrio GF, Fiorindi A, Lauretti L, Olivi A, Fontanella MM, Doglietto F. Quantitative Anatomical Studies in Neurosurgery: A Systematic and Critical Review of Research Methods. Life (Basel). 2023 Aug 28;13(9):1822. doi: 10.3390/life13091822.
PubMed 37763226Liu JK, Kshettry VR, Recinos PF, Kamian K, Schlenk RP, Benzel EC. Establishing a surgical skills laboratory and dissection curriculum for neurosurgical residency training. J Neurosurg. 2015 Nov;123(5):1331-8. doi: 10.3171/2014.11.JNS14902. Epub 2015 May 26.
PubMed 26052729Bohl MA, McBryan S, Spear C, Pais D, Preul MC, Wilhelmi B, Yeskel A, Turner JD, Kakarla UK, Nakaji P. Evaluation of a Novel Surgical Skills Training Course: Are Cadavers Still the Gold Standard for Surgical Skills Training? World Neurosurg. 2019 Jul;127:63-71. doi: 10.1016/j.wneu.2019.03.230. Epub 2019 Mar 28.
PubMed 30930320Berg DA, Milner RE, Fisher CA, Goldberg AJ, Dempsey DT, Grewal H. A cost-effective approach to establishing a surgical skills laboratory. Surgery. 2007 Nov;142(5):712-21. doi: 10.1016/j.surg.2007.05.011.
PubMed 17981192Tschabitscher M, Di Ieva A. Practical guidelines for setting up an endoscopic/skull base cadaver laboratory. World Neurosurg. 2013 Feb;79(2 Suppl):S16.e1-7. doi: 10.1016/j.wneu.2011.02.045. Epub 2011 Nov 7.
PubMed 22120404Kshettry VR, Mullin JP, Schlenk R, Recinos PF, Benzel EC. The role of laboratory dissection training in neurosurgical residency: results of a national survey. World Neurosurg. 2014 Nov;82(5):554-9. doi: 10.1016/j.wneu.2014.05.028. Epub 2014 May 27.
PubMed 24875190Ghosh SK. Paying respect to human cadavers: We owe this to the first teacher in anatomy. Ann Anat. 2017 May;211:129-134. doi: 10.1016/j.aanat.2017.02.004. Epub 2017 Mar 6.
PubMed 28279760Wilkinson TM. Getting consent into perspective. Clin Anat. 2014 Sep;27(6):844-6. doi: 10.1002/ca.22412. Epub 2014 May 2.
PubMed 24797429
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranio-spinal Neurosurgical Approaches: Qualitative and Quantitative Analysis and Validation of New Minimally Invasive Methods on Cadaveric Anatomical Models.
- ClinicalTrials.gov ID
- NCT07287462
- Acronym / sponsor ID
- Neuro_SURGEM / 7155
- Keywords
- Cranio-spinal surgery, Neurosurgery, Minimally invasive techniques, Surgical validation, Anatomical models, Cadaveric dissection, Neuroanatomy, Surgical training
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 17 Dec 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 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).
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cranio-Spinal Neurosurgical Approaches Using Cadaveric Specimens | – | Procedure: Standardized cranio-spinal neurosurgical approaches performed on donated cadaveric specimens to assess surgical exposure, feasibility, anatomical variation, and selected new techniques.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Standardized cranio-spinal neurosurgical approaches performed on donated cadaveric specimens to assess surgical exposure, feasibility, anatomical variation, and selected new techniques.Also: No other names or identifiers; refers only to standardized cranio-spinal neurosurgical approaches on cadaveric specimensThis 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. | Procedure or surgery | Cranio-Spinal Neurosurgical Approaches Using Cadaveric Specimens |
Primary outcome
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).
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
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 17 Dec 2025.
- Background: PubMed 28057590Schreiber A, Ferrari M, Rampinelli V, Doglietto F, Belotti F, Lancini D, Ravanelli M, Rodella LF, Fontanella MM, Nicolai P. Modular Endoscopic Medial Maxillectomies: Quantitative Analysis of Surgical Exposure in a Preclinical Setting. World Neurosurg. 2017 Apr;100:44-55. doi: 10.1016/j.wneu.2016.12.094. Epub 2017 Jan 3.
- Background: PubMed 30210974Muhanna N, Chan H, Qiu J, Daly M, Khan T, Doglietto F, Kucharczyk W, Goldstein DP, Irish JC, de Almeida JR. Volumetric Analysis of Endoscopic and Maxillary Swing Surgical Approaches for Nasopharyngectomy. J Neurol Surg B Skull Base. 2018 Oct;79(5):466-474. doi: 10.1055/s-0037-1617432. Epub 2018 Jan 19.
- Background: PubMed 28254536Jagersberg M, Brodard J, Qiu J, Mansouri A, Doglietto F, Gentili F, Kucharczyk W, Fasel J, Schaller K, Radovanovic I. Quantification of Working Volumes, Exposure, and Target-Specific Maneuverability of the Pterional Craniotomy and Its Minimally Invasive Variants. World Neurosurg. 2017 May;101:710-717.e2. doi: 10.1016/j.wneu.2017.02.011. Epub 2017 Feb 22.
- Background: PubMed 30592348Ferrari M, Schreiber A, Mattavelli D, Lombardi D, Rampinelli V, Doglietto F, Rodella LF, Nicolai P. Surgical anatomy of the parapharyngeal space: Multiperspective, quantification-based study. Head Neck. 2019 Mar;41(3):642-656. doi: 10.1002/hed.25378. Epub 2018 Dec 28.
- Background: PubMed 17110074Ebner FH, Koerbel A, Kirschniak A, Roser F, Kaminsky J, Tatagiba M. Endoscope-assisted retrosigmoid intradural suprameatal approach to the middle fossa: anatomical and surgical considerations. Eur J Surg Oncol. 2007 Feb;33(1):109-13. doi: 10.1016/j.ejso.2006.09.036. Epub 2006 Nov 14.
- Background: PubMed 30610300Doglietto F, Belotti F, Qiu J, Roca E, Radovanovic I, Agur A, Kucharczyk W, Schreiber A, Villaret AB, Nicolai P, Gentili F, Fontanella MM. Endonasal and Transoral Approaches to the Craniovertebral Junction: A Quantitative Anatomical Study. Acta Neurochir Suppl. 2019;125:37-44. doi: 10.1007/978-3-319-62515-7_6.
- Background: PubMed 29354486Doglietto F, Qiu J, Ravichandiran M, Radovanovic I, Belotti F, Agur A, Zadeh G, Fontanella MM, Kucharczyk W, Gentili F. Quantitative comparison of cranial approaches in the anatomy laboratory: A neuronavigation based research method. World J Methodol. 2017 Dec 26;7(4):139-147. doi: 10.5662/wjm.v7.i4.139. eCollection 2017 Dec 26.
- Background: PubMed 37763226Agosti E, De Maria L, Mattogno PP, Della Pepa GM, D'Onofrio GF, Fiorindi A, Lauretti L, Olivi A, Fontanella MM, Doglietto F. Quantitative Anatomical Studies in Neurosurgery: A Systematic and Critical Review of Research Methods. Life (Basel). 2023 Aug 28;13(9):1822. doi: 10.3390/life13091822.
- Background: PubMed 26052729Liu JK, Kshettry VR, Recinos PF, Kamian K, Schlenk RP, Benzel EC. Establishing a surgical skills laboratory and dissection curriculum for neurosurgical residency training. J Neurosurg. 2015 Nov;123(5):1331-8. doi: 10.3171/2014.11.JNS14902. Epub 2015 May 26.
- Background: PubMed 30930320Bohl MA, McBryan S, Spear C, Pais D, Preul MC, Wilhelmi B, Yeskel A, Turner JD, Kakarla UK, Nakaji P. Evaluation of a Novel Surgical Skills Training Course: Are Cadavers Still the Gold Standard for Surgical Skills Training? World Neurosurg. 2019 Jul;127:63-71. doi: 10.1016/j.wneu.2019.03.230. Epub 2019 Mar 28.
- Background: PubMed 17981192Berg DA, Milner RE, Fisher CA, Goldberg AJ, Dempsey DT, Grewal H. A cost-effective approach to establishing a surgical skills laboratory. Surgery. 2007 Nov;142(5):712-21. doi: 10.1016/j.surg.2007.05.011.
- Background: PubMed 22120404Tschabitscher M, Di Ieva A. Practical guidelines for setting up an endoscopic/skull base cadaver laboratory. World Neurosurg. 2013 Feb;79(2 Suppl):S16.e1-7. doi: 10.1016/j.wneu.2011.02.045. Epub 2011 Nov 7.
- 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.
Francesco Doglietto principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Minimally Invasive Techniques and Neurosurgical Procedures, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 3 inclusion and 3 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 17 Dec 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 Francesco Doglietto, MD, PhD (+3906 3015.4120, francesco.doglietto@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 NCT07287462, which also lists 21 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 17 Dec 2025.