Trials / Unknown
UnknownNCT04267575
Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Jerome Canady, M.D. · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Canady Helios Cold Plasma Scalpel | Device used to distribute cold plasma energy at the resected tumor margins. |
Timeline
- Start date
- 2019-07-30
- Primary completion
- 2021-04-14
- Completion
- 2023-04-14
- First posted
- 2020-02-13
- Last updated
- 2021-08-09
- Results posted
- 2021-08-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04267575. Inclusion in this directory is not an endorsement.