Key result
A practical stepwise approach and novel study design are proposed for the safe introduction and formal prospective ethical evaluation of new and experimental surgical procedures.
Why the study?
It is often unclear whether a new surgical intervention constitutes human experimentation, and there is no agreed protocol or equivalent phase I trial design for safety evaluation of experimental surgical procedures in a first-in-human setting.
Design
Review
Authors
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May guide ethical surgical innovation; leaves open prospective validation before clinical adoption.
Proposes a structured framework and study design for the safe, ethical introduction and first-in-human evaluation of novel surgical techniques.
Brown et al. (2019) reported a review. Stepwise approach for introducing new surgical procedures was evaluated. A practical stepwise approach and novel study design are proposed for the safe introduction and formal prospective ethical evaluation of new and experimental surgical procedures.
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