Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04267575
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Jerome Canady, M.D., Jerome Canady Research Institute for Advanced Biological & Technological Sciences

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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : February 28, 2021


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 :
  1. Number of Participants with Complications Due To Cold Plasma Application [ Time Frame: Immediate after application of cold plasma ]
    Complications secondary to the cold plasma application



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267575


Contacts
Layout table for location contacts
Contact: Jerome Canady, MD 301-270-0147 drjcanady@canadysurgicalgroup.com
Contact: Kimberly Wiley, MD 301-270-0147 drkwiley@usmedinnov.com

Locations
Layout table for location information
United States, District of Columbia
Canady Surgical Group PC Recruiting
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Jerome Canady, M.D.

Layout table for additonal information
Responsible Party: Jerome Canady, M.D., Sponsor-Investigator, Jerome Canady Research Institute for Advanced Biological & Technological Sciences
ClinicalTrials.gov Identifier: NCT04267575    
Other Study ID Numbers: G190165
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Fallopian Tube Neoplasms
Carcinoma, Renal Cell
Intestinal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Urogenital Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urologic Neoplasms
Urologic Diseases
Fallopian Tube Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Kidney Diseases