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RecruitingNCT06796634

Effects of Cold Atmospheric Plasma (CAP) on Peritoneal Tumor Tissue

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
5 (estimated)
Sponsor
University Hospital, Ghent · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

There are to date no studies available that have examined the effects of CAP on tumor tissue in patients. The aim of this study is to investigate these effects in patients undergoing surgery for peritoneal metastases. Tumor nodules will be treated with different durations and intensities of CAP before being surgically removed. The resected nodules will be analyzed for tumor vitality.

Conditions

Interventions

TypeNameDescription
DEVICEJ-plasma* Surgery and application of CAP: at the start of surgery, an inventory is made of suitable tumor nodules that will be planned for resection. Nodules should have a maximal size of 2-3 mm, since it is unlikely that bigger lesions can be adequately treated with CAP. * Selected tumor nodules will be treated with the J-plasma device at the standard settings (Helium gas flow of 4 l/min, coagulation and cutting intensity at 35). The distance between the tip of the device and the tissue will be approx. 10 mm. Using a timer and footswitch, nodules will be treated at different power settings and durations: * 15 W, 30W, or 45W * 2, 5, or 10 seconds. * The treated nodules will be resected at least 30 minutes after plasma treatment, and the exact timing will be documented. The samples are split in half: one half is fixed in formalin for histology and immune histochemistry, and the other half is immediately processed for live/death staining using flow cytometry.

Timeline

Start date
2024-08-21
Primary completion
2025-04-01
Completion
2025-04-01
First posted
2025-01-28
Last updated
2025-01-28

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT06796634. Inclusion in this directory is not an endorsement.

Effects of Cold Atmospheric Plasma (CAP) on Peritoneal Tumor Tissue (NCT06796634) · Clinical Trials Directory