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

NCT04267575 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-08-09

Study results available
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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.

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
  • 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

Interventions

DEVICE

Canady Helios Cold Plasma Scalpel

Device used to distribute cold plasma energy at the resected tumor margins.

Sponsors & Collaborators

  • Jerome Canady, M.D.

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-30
Primary Completion
2021-04-14
Completion
2023-04-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04267575 on ClinicalTrials.gov