Clinical trial · Observational
Link of Interest and Training Model
Evaluation of Ethical Implication of a Training Model Necessary to Gain Access to a Surgical Innovation Device.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| interview | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- expert
- description
- interviews of expert of pipac about ethical issues
- interventionNames
- Other: interview
Primary outcomes (1)
- measure
- qualitative analysis of the interviews
- timeFrame
- 1 month
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * expert in pipac * more than 30 PIPAC per year Exclusion Criteria: \-
References
Publications (1)
- DERIVEDMartellotto 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. PMID 32738543