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NCT04267575

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

Status unknown NA Results posted Last updated 9 August 2021
What this trial tests

NA trial testing Canady Helios Cold Plasma Scalpel in Recurrent Malignant Solid Neoplasm in 20 participants. Status unknown.

Timeline
30 July 2019
Primary endpoint
14 April 2021
14 April 2023

Quick facts

Lead sponsorJerome Canady, M.D.
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date30 July 2019
Primary completion14 April 2021
Estimated completion14 April 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Jerome Canady, M.D.

Who can join

18 and older, any sex, with Recurrent Malignant Solid Neoplasm or Stage IV Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Complications Due To Cold Plasma Application Primary · 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.

GroupValue95% CI
Primary Arm0
Primary Arm20

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Medical gas plasma technology: Roadmap on cancer treatment and immunotherapy.
    Bekeschus S. · · 2023 · cited 52× · PMID 37556976 · DOI 10.1016/j.redox.2023.102798
  2. The First Cold Atmospheric Plasma Phase I Clinical Trial for the Treatment of Advanced Solid Tumors: A Novel Treatment Arm for Cancer.
    Canady J, Murthy SRK, Zhuang T, Gitelis S, et al · · 2023 · cited 42× · PMID 37509349 · DOI 10.3390/cancers15143688
  3. Cold atmospheric plasmas target breast cancer stemness via modulating AQP3-19Y mediated AQP3-5K and FOXO1 K48-ubiquitination.
    Dai X, Cai D, Wang P, Nan N, et al · · 2022 · cited 29× · PMID 35637961 · DOI 10.7150/ijbs.72296
  4. Role of Short- and Long-Lived Reactive Species on the Selectivity and Anti-Cancer Action of Plasma Treatment In Vitro.
    Sklias K, Santos Sousa J, Girard PM. · · 2021 · cited 28× · PMID 33557129 · DOI 10.3390/cancers13040615
  5. Emerging innovations in cold plasma therapy against cancer: A paradigm shift.
    Kumar Dubey S, Dabholkar N, Narayan Pal U, Singhvi G, et al · · 2022 · cited 26× · PMID 35598703 · DOI 10.1016/j.drudis.2022.05.014
  6. Emerging innovations on exosome-based onco-therapeutics.
    Dai X, Ye Y, He F. · · 2022 · cited 24× · PMID 36119094 · DOI 10.3389/fimmu.2022.865245
  7. Cancer treatment with gas plasma and with gas plasma-activated liquid: positives, potentials and problems of clinical translation.
    Harley JC, Suchowerska N, McKenzie DR. · · 2020 · cited 22× · PMID 32757133 · DOI 10.1007/s12551-020-00743-z
  8. Cold atmospheric plasma: Novel opportunities for tumor microenvironment targeting.
    Dai X, Zhu K. · · 2023 · cited 14× · PMID 36762766 · DOI 10.1002/cam4.5491

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Other recruiting trials for Recurrent Malignant Solid Neoplasm

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing