Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04267575|
Recruitment Status : Active, not recruiting
First Posted : February 13, 2020
Results First Posted : August 9, 2021
Last Update Posted : August 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|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||Device: Canady Helios Cold Plasma Scalpel||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites|
|Actual Study Start Date :||July 30, 2019|
|Actual Primary Completion Date :||April 14, 2021|
|Estimated Study Completion Date :||April 14, 2023|
Experimental: Primary Arm
After the gross solid tumor is removed, cold plasma is sprayed in the area of the resected tumor margins.
Device: Canady Helios Cold Plasma Scalpel
Device used to distribute cold plasma energy at the resected tumor margins.
- Number of Participants With Complications Due To Cold Plasma Application [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267575
|United States, District of Columbia|
|Canady Surgical Group PC|
|Washington, District of Columbia, United States, 20010|