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← Stage IV recurrent Rectal Cancer

NCT04267575 · STUDY IN CONTEXT

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

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
nct id
NCT04267575
trial label
Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
1
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
    nct id
    NCT04267575
    outcome key
    om-0000
    source section id
    NCT04267575-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Complications Due To Cold Plasma Application
    endpoint definition
    Adverse events (CTCAE event version 4.03 to 5.0) within 30 days after Canady Helios Cold Plasma Scalpel treatment.
    time origin
    Immediate after application of cold plasma, followed by 3 months, 6 months, 12 months and 15 month observations.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
    nct id
    NCT04267575
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Primary Arm
    regimen
    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.
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04267575-om-0000#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-stage-iv-recurrent-dbf7a1d5
    nct id
    NCT04267575
    harm key
    EG000
    source section id
    NCT04267575-ae
    event group key
    EG000
    event group label
    Primary Arm
    serious affected
    0
    serious at risk
    20
    other affected
    0
    other at risk
    20
    frequency threshold
    0
    collection period
    Data has been collected for 16 months as of 5/21/21
    event definition
    There have been 0 adverse events.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice