Link of Interest and Training Model

Peritoneal Carcinomatosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04341337
• Other study ID #: pipac
• Status: Completed
• Start date: March 2, 2019
• Est. completion date: April 6, 2020

Study information

• Verified date: April 2020
• Source: Centre de l'arthrose, Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 6, 2020
• Est. primary completion date: April 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• expert in pipac

• more than 30 PIPAC per year

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Carcinoma
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms

Intervention

Other:
• interview
questionnaire about ethics in surgery

Locations

Country	Name	City	State
France	Université de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre de l'arthrose, Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	qualitative analysis of the interviews	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.	1 month