NCT04267575 · OUTCOME

Number of Participants With Complications Due To Cold Plasma Application

Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites · Source last updated 2021-08-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Immediate after application of cold plasma, followed by 3 months, 6 months, 12 months and 15 month observations.

What was measured

Adverse events (CTCAE event version 4.03 to 5.0) within 30 days after Canady Helios Cold Plasma Scalpel treatment.

Groups in this outcome

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Primary Arm	20

Reported measurements

Source class 1

Number of participants with complications secondary to cold plasma application

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Primary Arm	0	Not reported	Not reported	Not reported	Not reported

Number of patients receiving cold plasma application.

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Primary Arm	20	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
title
Number of participants with complications secondary to cold plasma application
measurements
group Id
OG000
value
20
title
Number of patients receiving cold plasma application.

denoms

counts
group Id
OG000
value
20
units
Participants

description

Adverse events (CTCAE event version 4.03 to 5.0) within 30 days after Canady Helios Cold Plasma Scalpel treatment.

groups

description
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.
id
OG000
title
Primary Arm

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

Immediate after application of cold plasma, followed by 3 months, 6 months, 12 months and 15 month observations.

title

Number of Participants With Complications Due To Cold Plasma Application

type

PRIMARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice