CI

At a glance

ClinicalIndex Comparison Record
N/AUnknown· 20 enrolled
Drug / intervention
Canady Helios Cold Plasma Scalpeldevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04267575
NCT04267575N/AUnknown

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

Jerome Canady, M.D.·interventional·Posted Feb 13, 2020·Updated Aug 9, 2021

In Brief

A clinical study evaluating Canady Helios Cold Plasma Scalpel for Recurrent Malignant Solid Neoplasm and 15 related conditions. Targeting 20 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/AUnknownOverdue
2020202120222023202420252026
First PostedFeb 13, 2020
Enrollment StartJul 30, 2019
Primary CompletionApr 14, 2021
Study CompletionApr 14, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.4 years ago

Interventions

Canady Helios Cold Plasma Scalpeldevice

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