Canady Helios Cold Plasma Scalpel Treatment At The Surgical Margin And Macroscopic Tumor Sites

Study Overview

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

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.

N/A

Recurrent Malignant Solid Neoplasm
Stage IV Breast Cancer
Stage IV Prostate Cancer
Stage IV Pancreatic Cancer
Stage IV Non-small Cell Lung Cancer
Stage IV Ovarian Cancer
Stage IV Fallopian Tube Cancer
Stage IV Colon Cancer
Stage IV Colorectal Cancer
Stage IV Liver Cancer
Stage IV Renal Cell Cancer
Stage IV Rectal Cancer
Stage IV Lung Cancer
Stage IV Small Intestinal Cancer
Stage IV Gastric Cancer
Stage IV Bladder Cancer

DEVICE: Canady Helios Cold Plasma Scalpel

G190165

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-02-11	Results First Submitted 2021-07-16	Last Update Submitted that met QC Criteria 2021-07-16
First Submitted that Met QC Criteria 2020-02-11	Results First Submitted that Met QC Criteria 2021-07-16	Last Update Posted (ACTUAL) 2021-08-09
First Posted (ACTUAL) 2020-02-13	Results First Posted 2021-08-09	Last Verified 2021-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Primary Arm After the gross solid tumor is removed, cold plasma is sprayed in the area of the resected tumor margins.	DEVICE: Canady Helios Cold Plasma Scalpel Device used to distribute cold plasma energy at the resected tumor margins.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Primary Arm

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

DEVICE: Canady Helios Cold Plasma Scalpel

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

Primary Outcome Measures	Measure Description	Time Frame
Number of Participants With Complications Due To Cold Plasma Application	Adverse events (CTCAE event version 4.03 to 5.0) within 30 days after Canady Helios Cold Plasma Scalpel treatment.	Immediate after application of cold plasma, followed by 3 months, 6 months, 12 months and 15 month observations.

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Solid tumors undergoing surgical treatment 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).
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study and must be willing to return for follow-up
18 years of age or older and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with Good Clinical Practice (GCP) guidelines and institutional policy.
Biopsy (histopathology or cytology) diagnosis of a solid tumor as defined by the World Health Organization (WHO) or by cross-sectional imaging reviewed by a board-certified radiologist.
Good performance status (ECOG < 2), Karnofsky >60%,
Patients with low or acceptable surgical risk (American society of Anesthesiology (ASA) score of 3 or less.
Patient is a candidate for surgical therapy as discussed and recommended by the institutional disease management team (DMT, Tumor Board).

Absolute neutrophil count (ANC) exceeds 1200/mm3, white blood cell count exceeds 4000/mm3 and platelet count is greater than 100,000/mm3
An international normalized ratio (INR) ≤ 1.5 (patients who are therapeutically anticoagulated for non-related medical conditions such as atrial fibrillation and whose anti-thrombotic treatment can be withheld for operation will be eligible).
Adequate hepatic function must be met as evidenced by total serum bilirubin ≤ 3.0 mg/dl ; alkaline phosphatase < 2.5 times the upper limit of normal; and, aspartate aminotransferase (AST) less than 1.5 times upper limit of normal [alkaline phosphatase and AST cannot both exceed the upper limit of normal]
Serum renal functional parameters, blood urea nitrogen (BUN) and creatinine are within normal limits
For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
Life expectancy of at least six months

Patients with unresectable tumors as decided by a multidisciplinary disease management team
Patients with multiple metastatic sites not amenable for surgical resection
Pregnancy or lactation
Patients with low performance status (ECOG > 2 or Karnofsky < 60%)
Any one or more of the following hematological abnormalities
Hgb < 8gm/dl unable to be corrected with transfusion
Absolute Neutrophil Count < 1200/mm3
White blood cell count < 4000/mm3
Platelet count < 100,000/mm3
INR > 1.5 (except in patients who are therapeutically AST anticoagulated for non-related medical conditions such as atrial fibrillation and whose anti-thrombotic treatment cannot be withheld for operation will be eligible)
History of hepatic cirrhosis or present hepatic dysfunction
Alkaline phosphatase ≥ 2.5 times the upper limit of normal
≥ 1.5 times upper limit of normal
Serum bilirubin > 3.0 mg/dl
Alkaline phosphatase and AST both exceed the upper limit of normal
Renal insufficiency indicated by a serum creatinine >1.5mg/dL.
Patients with high surgical risk (ASA 4-5) with significant history of a medical problem that would preclude the patient from undergoing an operative procedure such as a history of severe congestive heart failure or active ischemic heart disease.
Febrile illness within 7 days before scheduled surgery
Treatment with another investigational drug or other intervention within 60 days before surgery
Patients that are unable to- or unwilling to provide a written informed consent
Patients who underwent treatment with cold plasma within a year before study entry.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Canady J, Murthy SRK, Zhuang T, Gitelis S, Nissan A, Ly L, Jones OZ, Cheng X, Adileh M, Blank AT, Colman MW, Millikan K, O'Donoghue C, Stenson KM, Ohara K, Schtrechman G, Keidar M, Basadonna G. The First Cold Atmospheric Plasma Phase I Clinical Trial for the Treatment of Advanced Solid Tumors: A Novel Treatment Arm for Cancer. Cancers (Basel). 2023 Jul 20;15(14):3688. doi: 10.3390/cancers15143688.

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Clinical Trial Record