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NCT04267575 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      20
    units
    Participants
groups
  1. 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
    BG000
    title
    Primary Arm
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          14
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14
          value
          59
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          18
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      denoms
      1. counts
        1. group Id
          BG000
          value
          15
        units
        Participants
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          5
        units
        Participants
      title
      Israel
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The population was split between 2 institutional medical centers. The study was started in Israel, and completed in the United States.
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Recurrent Colon Cancer
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Recurrent Ovarian Cancer
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Recurrent Anal Squamous Carcinoma to the Liver (HPV Related)
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Recurrent Mesothelioma to the abdominal wall
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Recurrent Colon Cancer to the retroperitoneum
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Recurrent Myxofibrosarcoma to the chest wall
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Recurrent Breast Carcinoma to the right hip
      8. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Recurrent Non-Small cell lung Adenocarcinoma to the left/hip/upper end of femur
      9. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Renal Cell Carcinoma to the left clavicle
      10. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Cholangiocarcinoma to the left elbow/distal humerus
      11. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Non-Small Cell Lung Carcinoma (NSCLC) to right hip
      12. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Pleomorphic Sarcoma to the left distal femur
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor Type
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      20
    units
    Participants
groups
  1. 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
    BG000
    title
    Primary Arm
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          14
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14
          value
          59
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          18
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      denoms
      1. counts
        1. group Id
          BG000
          value
          15
        units
        Participants
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          5
        units
        Participants
      title
      Israel
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The population was split between 2 institutional medical centers. The study was started in Israel, and completed in the United States.
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Recurrent Colon Cancer
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Recurrent Ovarian Cancer
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Recurrent Anal Squamous Carcinoma to the Liver (HPV Related)
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Recurrent Mesothelioma to the abdominal wall
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Recurrent Colon Cancer to the retroperitoneum
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Recurrent Myxofibrosarcoma to the chest wall
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Recurrent Breast Carcinoma to the right hip
      8. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Recurrent Non-Small cell lung Adenocarcinoma to the left/hip/upper end of femur
      9. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Renal Cell Carcinoma to the left clavicle
      10. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Cholangiocarcinoma to the left elbow/distal humerus
      11. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Non-Small Cell Lung Carcinoma (NSCLC) to right hip
      12. measurements
        1. group Id
          BG000
          value
          1
        title
        Metastatic Pleomorphic Sarcoma to the left distal femur
      denoms
      1. counts
        1. group Id
          BG000
          value
          20
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor Type
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice