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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04267575
Other study ID # G190165
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 30, 2019
Est. completion date April 14, 2023

Study information

Verified date July 2021
Source Jerome Canady Research Institute for Advanced Biological & Technological Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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Study Design


Intervention

Device:
Canady Helios Cold Plasma Scalpel
Device used to distribute cold plasma energy at the resected tumor margins.

Locations

Country Name City State
United States Canady Surgical Group PC Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Jerome Canady, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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