Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 30, 2019
CompletedFirst Submitted
Initial submission to the registry
February 11, 2020
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2021
CompletedResults Posted
Study results publicly available
August 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2023
CompletedAugust 9, 2021
July 1, 2021
1.7 years
February 11, 2020
July 16, 2021
July 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
Primary Arm
EXPERIMENTALAfter the gross solid tumor is removed, cold plasma is sprayed in the area of the resected tumor margins.
Interventions
Device used to distribute cold plasma energy at the resected tumor margins.
Eligibility Criteria
You may qualify if:
- 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
- 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).
- 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.
- +1 more criteria
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Canady Surgical Group PC
Washington D.C., District of Columbia, 20010, United States
Related Publications (1)
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.
PMID: 37509349DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Coronavirus Disease 2019 (COVID-19) global pandemic prolonged the duration of the study.
Results Point of Contact
- Title
- Jerome Canady, M.D.
- Organization
- Jerome Canady Research Institute for Advanced Biological and Technological Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
February 11, 2020
First Posted
February 13, 2020
Study Start
July 30, 2019
Primary Completion
April 14, 2021
Study Completion
April 14, 2023
Last Updated
August 9, 2021
Results First Posted
August 9, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share