Trial Outcomes & Findings for Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites (NCT NCT04267575)
NCT ID: NCT04267575
Last Updated: 2021-08-09
Results Overview
Adverse events (CTCAE event version 4.03 to 5.0) within 30 days after Canady Helios Cold Plasma Scalpel treatment.
Recruitment status
UNKNOWN
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Immediate after application of cold plasma, followed by 3 months, 6 months, 12 months and 15 month observations.
Results posted on
2021-08-09
Participant Flow
Participant milestones
| Measure |
Primary Arm
After the gross solid tumor is removed, cold plasma is sprayed in the area of the resected tumor margins.
Canady Helios Cold Plasma Scalpel: Device used to distribute cold plasma energy at the resected tumor margins.
Post-operatively, patients will be started back on Adjuvant chemotherapy, radiation, or immuno-therapy as per medical oncology and multi-disciplinary team.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The population was split between 2 institutional medical centers. The study was started in Israel, and completed in the United States.
Baseline characteristics by cohort
| Measure |
Primary Arm
n=20 Participants
After the gross solid tumor is removed, cold plasma is sprayed in the area of the resected tumor margins.
Canady Helios Cold Plasma Scalpel: Device used to distribute cold plasma energy at the resected tumor margins.
Post-operatively, patients will be started back on Adjuvant chemotherapy, radiation, or immuno-therapy as per medical oncology and multi-disciplinary team.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=20 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 14 • n=20 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants • The population was split between 2 institutional medical centers. The study was started in Israel, and completed in the United States.
|
|
Region of Enrollment
Israel
|
5 Participants
n=5 Participants • The population was split between 2 institutional medical centers. The study was started in Israel, and completed in the United States.
|
|
Tumor Type
Metastatic Recurrent Colon Cancer
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Recurrent Ovarian Cancer
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Recurrent Anal Squamous Carcinoma to the Liver (HPV Related)
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Recurrent Mesothelioma to the abdominal wall
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Recurrent Colon Cancer to the retroperitoneum
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Recurrent Myxofibrosarcoma to the chest wall
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Recurrent Breast Carcinoma to the right hip
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Recurrent Non-Small cell lung Adenocarcinoma to the left/hip/upper end of femur
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Renal Cell Carcinoma to the left clavicle
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Cholangiocarcinoma to the left elbow/distal humerus
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Non-Small Cell Lung Carcinoma (NSCLC) to right hip
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Pleomorphic Sarcoma to the left distal femur
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Recurrent Chordoma to the right gluteal posterior thigh
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Recurrent Melanoma to the left pelvis
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Pleomorphic Spindle Cell Sarcoma to the humerus
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Recurrent Squamous Cell Carcinoma to the left hand and left axillary lymph node
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Angiosarcoma of the right breast to the contralateral left breast and axilla
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Recurrent Non-Small Cell Lung Carcinoma (NSCLC) to the left hemipelvis
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Desmoplastic Small Round Cell Sarcoma (DSRCS) of left inguinal lymph node and testicle
|
1 Participants
n=20 Participants
|
|
Tumor Type
Metastatic Recurrent Adenoid Cystic Carcinoma of the neck
|
1 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Primary Arm
n=20 Participants
After the gross solid tumor is removed, cold plasma is sprayed in the area of the resected tumor margins.
Canady Helios Cold Plasma Scalpel: Device used to distribute cold plasma energy at the resected tumor margins.
Post-operatively, patients will be started back on Adjuvant chemotherapy, radiation, or immuno-therapy as per medical oncology and multi-disciplinary team.
|
|---|---|
|
Number of Participants With Complications Due To Cold Plasma Application
Number of participants with complications secondary to cold plasma application
|
0 Participants
|
|
Number of Participants With Complications Due To Cold Plasma Application
Number of patients receiving cold plasma application.
|
20 Participants
|
Adverse Events
Primary Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jerome Canady, M.D.
Jerome Canady Research Institute for Advanced Biological and Technological Sciences
Phone: 301-270-0147
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60