Table 1

Participant timeline

Study phaseScreening phaseTreatment phaseObservation phaseTermination
Approval rangeDays 0–7Day 1Day 2+3 daysDay28±14 days
Informed consentX
Baseline characteristics*X
Vital signXX
Complete blood count XX
Serum biochemistry XX
Coagulation test X
Electrocardiograph X
Abdominal radiographyX
Endoscopy X
Histopathological diagnosis on biopsy sample X
Assessment of the technical difficulty§ X
Procedure timeXX
Efficacy-related outcomesXXX
Safety-related outcomesXXXX
Device-related outcomesXX
  • *Age, performance status, pregnant or lactating, history of critical organ (liver/renal/heart) failure, history of bleeding disorders, registration history for the present trial, the possibility of discontinuing antithrombotic drugs in accordance with guidelines will be interviewed.

  • †All assessments must be completed within 4 weeks prior to consent.

  • ‡All assessments must be completed within 12 weeks prior to consent.

  • §Based on the information regarding the operator, endoknife and injectional solution, the technical difficulty will be assessed.