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NCT05561920 · ADVERSE EVENTS

Adverse events

Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients · Source last updated 2026-03-31

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
50 minutes
Other-event reporting threshold
0%

Aim of this study is to describe phonatory movement of pharyngoesophageal segment in laryngectomy patients with HSV and then with biomechanical model, analyse these recordings and examine relationship between the obtained parameters and the parameters obtained using the acoustic analysis of the voice of a laryngectomized person.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Adult Laryngectomised Patients

Patients who have undergone total laryngectomy and completed minimal their 6-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy High - speed video endoscopy (HSV): Describe anatomical and morphological characteristics o phonatory movement of Pharyngoesophageal segment (PES) in laryngectomy patients Acoustic voice analysis: acoustic program (lingWAVES - Voice and speech analyser) - measuring the values of acoustic parameters in voice recordings Quality of life questionnaire: Filling out questionnaires

0 / 550 / 550 / 55

Group identifiers: EG000: Adult Laryngectomised Patients

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.

      Complete source fields
      description
      Aim of this study is to describe phonatory movement of pharyngoesophageal segment in laryngectomy patients with HSV and then with biomechanical model, analyse these recordings and examine relationship between the obtained parameters and the parameters obtained using the acoustic analysis of the voice of a laryngectomized person.
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        55
        description
        Patients who have undergone total laryngectomy and completed minimal their 6-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy High - speed video endoscopy (HSV): Describe anatomical and morphological characteristics o phonatory movement of Pharyngoesophageal segment (PES) in laryngectomy patients Acoustic voice analysis: acoustic program (lingWAVES - Voice and speech analyser) - measuring the values of acoustic parameters in voice recordings Quality of life questionnaire: Filling out questionnaires
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        55
        serious Num Affected
        0
        serious Num At Risk
        55
        title
        Adult Laryngectomised Patients
      frequency Threshold
      0
      time Frame
      50 minutes

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

      Preserved source evidence · Not medical advice