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Assessment of Different Modified POEM for Achalasia

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Final enrollment: 69 participants (planned 52) · Eligibility criteria expanded, about 11 words · Secondary endpoints: details revised at 3 of 9 entries · 3 more Show 6 more changesShow less
    • Final enrollment: 69 participants (planned 52)
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 3 of 9 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 8 of 8 entries
  2. Secondary endpoints: details revised at 2 of 9 entriesv7
  3. Enrollment target: 325 to 52 Primary endpoints: 4 to 1 · Interventions: conventional myotomy (Procedure), full-thickness myotomy (Procedure), short myotomy (Procedure), tailored myotomy (Procedure) to conventional myotomy (Procedure), full-thickness myotomy (Procedure) · Secondary endpoints: 3 to 9 · 3 morev6 Show 6 more changesShow less
    • Primary endpoints: 4 to 1
    • Interventions: conventional myotomy (Procedure), full-thickness myotomy (Procedure), short myotomy (Procedure), tailored myotomy (Procedure) to conventional myotomy (Procedure), full-thickness myotomy (Procedure)
    • Secondary endpoints: 3 to 9
    • Study description shortened, about 160 words
    • Study arms: 4 to 2
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Sep 2025 to Dec 30, 2025 Completion date: Dec 2025 to May 30, 2026v5 Show 1 more changeShow less
    • Completion date: Dec 2025 to May 30, 2026
  5. Primary completion date: Dec 2025 to Sep 2025 Completion date: Dec 2027 to Dec 2025v4 Show 1 more changeShow less
    • Completion date: Dec 2027 to Dec 2025
  6. 2 versions Re-verified since Mar 3, 2022, no change to tracked fieldsv2-v3
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The aims of this study is to compare the efficacy and safety of conventional myotomy (circular myotomy) and modified myotomy (full-thickness myotomy) in the treatment of achalasia patients.
Trial Details
NCT Number NCT04578769
Lead Sponsor Peking Union Medical College Hospital
Conditions Esophageal Achalasia
Enrollment 69 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov