NCT04341337

Link of Interest and Training Model

Evaluation of Ethical Implication of a Training Model Necessary to Gain Access to a Surgical Innovation Device.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Centre de l'arthrose, Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

* The surgical device used to perform PIPAC procedure is commercialized by a single manufacturer under a monopoly regimen, and a formal training (economically supported by the manufacturer) is mandatory for surgeons who want to buy the device.Relations with the company and solutions to extend training require specific analysis from an ethical point of view. * Based on the growing number of published papers from a growing number of international centers, the controlled training model is not limiting, and it is a successful model of development of this breakthrough innovation. * But with the major involvement of the industry and the control of training, the different levels of interest could induce ethical questions.

Detailed description

* Objective: Using the example of Pressurized Intra Peritoneal Aerosol Chemotherapy (PIPAC), the investigators analyze the development model of this procedure and provide an ethical analysis of the involvement of the industry in this development. * Summary Background Data: In the case of breakthrough innovation, medical training is essential for safe use of the new procedure. Pharmaceutical companies may organize this training; but when it becomes the only training opportunity to use the device, scientists and clinicians are exposed to a conflict of interest. * Methods: The investigators performed a literature review of PIPAC publications using the STROBE criteria. Then, the investigators conducted interviews with an expert panel to analyze the ethical impact of involvement of the industry in the development of the PIPAC procedure.

Conditions

• Peritoneal Carcinomatosis

Interventions

Type	Name	Description
OTHER	interview	questionnaire about ethics in surgery

Timeline

• Start date: 2019-03-02
• Primary completion: 2020-04-06
• Completion: 2020-04-06
• First posted: 2020-04-10
• Last updated: 2020-04-29

Locations

1 site across 1 country: France