A Post-Market Clinical Follow-up of EARFOLD® Implantable Clip System in general surgical practice

Study type

• Study topic:
  Medical device
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  Patients who receive at least one EARFOLD® implant.
• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  30

Study design details

• Main study objective:
  Characterise and assess the incidence rates of • Infections • Re-operations • Erosions in patients who receive at least one EARFOLD® implant.
• Outcomes:
  Infection Rates Re-operation Rates Erosion Rates, Other AEs
• Data analysis plan:
  Descriptive data analysis only. The proportion of infections, re-operations, erosions and other complications of interest will be calculated. The data will be compared to a summary of AEs associated with conventional otoplasty obtained from a systematic review of the literature.