NCT04904042

Study of Safety and Efficiency of the Use of Neutral Argon Plasma in Cyto-reduction of Miliary Implants in the Peritoneal Surface.

Phase I/II Study of Efficiency and Single-arm Safety on the Use of Neutral Argon Plasma in Cyto-reduction of Miliary Implants in the Peritoneal Surface.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Maimónides Biomedical Research Institute of Córdoba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Neutral argon plasma vaporization shows little damage to normal tissue and allows a complete removal of tumor tissue, that is, without leaving any cell debris viable tumor. Our primary objective is to evaluate the effectiveness and safety of neutral argon plasma on peritoneal implants with different dosimetry in vivo and ex vivo.

Conditions

• Peritoneal Carcinomatosis

Interventions

Type	Name	Description
DEVICE	Use of plasma of neutral argon	Evaluation of the mesentery or peritoneum area infiltrated by miliary implants that is going to be treated. Determination of the PCI. Collection of several samples of the mesenteric peritoneum or parietal peritoneum with tumor involvement (implants between 1-2.5mm of diameter). It will established a matrix which will be divided into 12 quadrants where the tissue with implants will be placed and it will be treated according to specific power (80-100%), and for an action time of 2-4 seconds or until macroscopic tumor destruction. For each power, application of Plasmajet at 1, 2 and 3 cm from the target tumor tissue. The in-vivo effect will be evaluated with the use of ball-tip in terms of damage to the serosa or vascularization of the mesentery.

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-04-03
• Completion: 2022-05-03
• First posted: 2021-05-27
• Last updated: 2022-06-02

Locations

1 site across 1 country: Spain