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

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

INTRODUCTION

  • Org Study ID: G190165
  • Secondary ID: N/A
  • NTC ID: NCT04267575
  • Sponsor: Jerome Canady, M.D.

BRIEF SUMMARY

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.

  • Overall Status
    Recruiting
  • Start Date
    July 30, 2019
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of Participants with Complications Due To Cold Plasma Application

Primary Outcome 1 - Timeframe: Immediate after application of cold plasma

CONDITION

  • 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

ELIGIBILITY

Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
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 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).
At the time of enrollment:
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
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 301-270-0147, 301-270-0147

Email: drjcanady@canadysurgicalgroup.com, drkwiley@usmedinnov.com

LOCATION

Facility Status Contact
Facility: Canady Surgical Group PC
Washington, District of Columbia 20010
United States
Status: Recruiting Contact: N/A