Link of Interest and Training Model

* 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.

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Key information

Conditions

Peritoneal Carcinomatosis Abdominal Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Université de Paris

Paris, 75011, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

expert in pipac
more than 30 PIPAC per year

Exclusion criteria

Treatment and study plan

interview

Other

questionnaire about ethics in surgery

Primary outcomes

qualitative analysis of the interviews

Time frame: 1 month

Questions for interviews were first prepared. Six questions for the clinicians and the scientist were elaborated about the interviewees' experience concerning the initiation and use of PIPAC, difficulties encountered to initiate this activity in their respective centres, description of the involvement of the industry for the development of the technique, the clinician-industry relationship, the mandatory nature of the training, and their ethical judgment on this model. For the biomedical manager, questions were about the set-up of the PIPAC procedure and the implication of the industry in the process. The commercial representative was interviewed about the business strategy of the industry. The interviewer had the freedom to adapt questions to prior answers. Interviewees did not receive the questionnaire before the discussion.

Sponsors and collaborators

Lead sponsor

Centre de l'arthrose, Paris

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Apr 10, 2020
Registry last updated: Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed