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CompletedNCT04341337Updated Apr 29, 2020

Link of Interest and Training Model

An observational study in Peritoneal Carcinomatosis, sponsored by Centre de l'arthrose, Paris. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-29.

Sponsored by Centre de l'arthrose, Paris · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
5
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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.
02

Conditions studied

  • Peritoneal Carcinomatosis
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 5 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Centre de l'arthrose, Paris is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

expert working in academic tertiary center

Inclusion criteria

  • expert in pipac
  • more than 30 PIPAC per year

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
5 participants (actual)
Patient registry
No

Groups and cohorts

  • expert

    interviews of expert of pipac about ethical issues

    Other: interview

Interventions

  • Otherinterview

    questionnaire about ethics in surgery

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month

07

Study locations

1 site
  • Université de Paris
    Paris, 75011, France
08

References and documents

Publications

  • Martellotto S, Maillot C, Villeneuve L, Eveno C, Sgarbura O, Pocard M. Restricted access to innovative surgical technique related to a specific training, is it ethical? Example of the PIPAC procedure. A systematic review and an experts survey. Int J Surg. 2020 Nov;83:235-245. doi: 10.1016/j.ijsu.2020.07.004. Epub 2020 Jul 29. PubMed 32738543 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04341337
Lead sponsor
Centre de l'arthrose, Paris
Responsible party
Maillot Cédric (principal investigator, Centre de l'arthrose, Paris) — Principal investigator
First posted
Apr 10, 2020
Start date
Mar 2, 2019
Primary completion
Apr 6, 2020
Completion
Apr 6, 2020
Last update
Apr 29, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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