Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00748085 · ADVERSE EVENTS

Adverse events

CryoSpray Ablation(tm)in Malignant Airway Disease to Determine Safety, and Tissue Effect in the Lung (ICE the MAD) · Source last updated 2015-07-23

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
1-all Subjects

CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.

0 / 51 / 5Not reported / Not reported

Group identifiers: EG000: 1-all Subjects

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      Vertigo
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      chest pain
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      Fatigue
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      other-Hoarseness
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      dyspnea
    Complete source fields
    event Groups
    1. description
      CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
      id
      EG000
      other Num Affected
      1
      other Num At Risk
      5
      serious Num Affected
      0
      serious Num At Risk
      5
      title
      1-all Subjects
    frequency Threshold
    0
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      Vertigo
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      chest pain
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      Fatigue
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      other-Hoarseness
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      dyspnea

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

    Preserved source evidence · Not medical advice