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Small Intestine Cancer

After the gross solid tumor is removed, cold plasma is sprayed in the area of the resected tumor margins.

Device used to distribute cold plasma energy at the resected tumor margins.

Canady Helios Cold Plasma Scalpel

The study designed is to evaluate the safety of Canady Helios™ Cold Plasma Scalpel (CHCPS) in patients with solid tumors with carcinomatosis scheduled to undergo surgical resection for cytoreduction. Patients with stage 4 resectable tumors as decided by a multidisciplinary disease management team may be included if the metastatic disease is non-synchronous (e.g. recurrent colorectal carcinoma with hepatic metastasis amenable for surgical resection).. Plasma is an ionized gas typically generated in high-temperature laboratory conditions. Plasma coagulators are currently used routinely as surgical tools with multiple applications that create temperatures between 37° C to 43°C and cause thermal injury. Earlier studies demonstrated the non-aggressive nature of cold plasma. As evidence accumulates, it is becoming clear that low-temperature cold plasma has an increasing role in biomedical applications.

Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites

Adverse events (CTCAE event version 4.03 to 5.0) within 30 days after Canady Helios Cold Plasma Scalpel treatment.

Jerome Canady, M.D.

Sponsor-Investigator

Patients received previous chemotherapy, radiation, immuno-therapy and/or surgery prior to metastatic recurrent disease. In this study, the patients gross solid tumor was removed, and cold plasma was sprayed in the area of the resected tumor margins.

Canady Helios Cold Plasma Scalpel: Device used to distribute cold plasma energy at the resected tumor margins.

Post-operatively, patients will be started back on Adjuvant chemotherapy, radiation, or immuno-therapy as per medical oncology and multi-disciplinary team.

Primary Arm

After the gross solid tumor is removed, cold plasma is sprayed in the area of the resected tumor margins.

Canady Helios Cold Plasma Scalpel: Device used to distribute cold plasma energy at the resected tumor margins.

Post-operatively, patients will be started back on Adjuvant chemotherapy, radiation, or immuno-therapy as per medical oncology and multi-disciplinary team.

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Israel

The population was split between 2 institutional medical centers. The study was started in Israel, and completed in the United States.

Region of Enrollment

Tumor Type

Coronavirus Disease 2019 (COVID-19) global pandemic prolonged the duration of the study.

Number of Participants With Complications Due To Cold Plasma Application

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites	NCT04267575	Recurrent Malig... Stage IV Breast... Stage IV Prosta... Stage IV Pancre... Stage IV Non-sm... Stage IV Ovaria... Stage IV Fallop... Stage IV Colon ... Stage IV Colore... Stage IV Liver ... Stage IV Renal ... Stage IV Rectal... Stage IV Lung C... Stage IV Small ... Stage IV Gastri... Stage IV Bladde...	Canady Helios C...	18 Years -	Jerome Canady Research Institute for Advanced Biological & Technological Sciences
Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites	NCT04267575	Recurrent Malig... Stage IV Breast... Stage IV Prosta... Stage IV Pancre... Stage IV Non-sm... Stage IV Ovaria... Stage IV Fallop... Stage IV Colon ... Stage IV Colore... Stage IV Liver ... Stage IV Renal ... Stage IV Rectal... Stage IV Lung C... Stage IV Small ... Stage IV Gastri... Stage IV Bladde...	Canady Helios C...	18 Years -	Jerome Canady Research Institute for Advanced Biological & Technological Sciences

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