Recurrent Malignant Solid NeoplasmNCT04267575
Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites
A study testing Canady Helios Cold Plasma Scalpel in people with Recurrent Malignant Solid Neoplasm and Stage IV Breast Cancer, run by Jerome Canady, M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Malignant Solid Neoplasm, Stage IV Breast Cancer, Stage IV Prostate Cancer
- What is being tested?
- Canady Helios Cold Plasma Scalpel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2019to 14 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Canady Surgical Group PC
Washington D.C., District of Columbia, 20010
About this study
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.
- Conditions
- 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
- Being tested
- Canady Helios Cold Plasma Scalpel
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms, Fallopian Tube Neoplasms, Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canady Helios Cold Plasma ScalpelDevice
Device used to distribute cold plasma energy at the resected tumor margins.
| Study group | Role | What they receive |
|---|---|---|
| Primary Arm | Experimental | After the gross solid tumor is removed, cold plasma is sprayed in the area of the resected tumor margins. Receives: Device: Canady Helios Cold Plasma Scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediate after application of cold plasma, followed by 3 months, 6 months, 12 months and 15 month observations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start30 Jul 2019
- Primary completion14 Apr 2021
- Study completion14 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Malignant Solid NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jerome Canady, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jerome Canady, M.D., Jerome Canady Research Institute for Advanced Biological & Technological Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267575
- Sponsor's protocol ID
- G190165
- Status last verified
- Jul 2021
- First submitted
- 11 Feb 2020
- Last updated
- 9 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 37509349
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites
- ClinicalTrials.gov ID
- NCT04267575
- Acronym / sponsor ID
- G190165
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jerome Canady, M.D.University, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 14 Apr 2021 (actual)
- Study completion
- 14 Apr 2023 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Posted 9 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Arm | Experimental | Device: Canady Helios Cold Plasma ScalpelAfter the gross solid tumor is removed, cold plasma is sprayed in the area of the resected tumor margins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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 Good Clinical Practice (GCP) guidelines and institutional policy.
Key exclusion criteria (22 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Canady Helios Cold Plasma ScalpelDevice used to distribute cold plasma energy at the resected tumor margins. | Device | Primary Arm |
Primary outcome
Number of Participants With Complications Due To Cold Plasma Application
Time frame: Immediate after application of cold plasma, followed by 3 months, 6 months, 12 months and 15 month observations.
Adverse events (CTCAE event version 4.03 to 5.0) within 30 days after Canady Helios Cold Plasma Scalpel treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37509349Canady 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canady Helios Cold Plasma Scalpel in people with Recurrent Malignant Solid Neoplasm and Stage IV Breast Cancer, run by Jerome Canady, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Complications Due To Cold Plasma Application (time frame: Immediate after application of cold plasma, followed by 3 months, 6 months, 12 months and 15 month observations.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04267575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.