Affiliations: [a] Department of Gynecology, Leiden University Medical Centre, Leiden, The Netherlands | [b] Department of Gynecology, Radboud University Medical Centre, Nijmegen, The Netherlands | [c] Department of Gynecology, Bronovo Hospital, The Hague, The Netherlands | [d] Department of BioMechanical Engineering, Delft University of Technology, Delft, The Netherlands
Correspondence:
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Corresponding author: Frank Willem Jansen, Leiden University Medical Center, Department of Gynecology, PO Box 9600, 2300 RC Leiden, The Netherlands. Tel.: +31 71 5262871; Fax: +31 71 5248181; E-mail: [email protected].
Abstract: BACKGROUND: New technology should be extensively tested before it is tried on patients. Unfortunately representative models are lacking. In theory, fresh frozen human cadavers are excellent models. OBJECTIVE: To identify strengths and weaknesses of fresh frozen human cadavers as research models for new technology prior to implementation in gynecological surgery. METHODS: During pre-clinical validation studies regarding the MobiSep uterine manipulator, test procedures were performed on fresh frozen cadavers. Both the experimental setup as the performance of the prototype were assessed. RESULTS: Five tests including six human cadavers were performed. Major changes were made to the MobiSep prototype design. The cadavers of two tests closely resembled surgical experiences as found in live patients. The anatomy of 4 of the 6 cadavers was not fully representative due to atrophy of the internal genitalia caused by age and due to the presence of pathology such extensive tumorous tissue. CONCLUSION: The cadaver tests provided vital information regarding design and functionality, that failed to emerge during the in-vitro testing. However, experiments are subject to anatomical uncertainties or restrictions. Consequently, the suitability of a cadaver should be carefully assessed before it is used for testing new technology.
Keywords: Laparoscopy, hysterectomy, technology, medical devices, innovation
