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Standard Versus Oesophago-gastric Junction Complex Myotomy for Treatment naïve Type 2 Achalasia Patients

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 10, 2025 (before its estimated June 14, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Primary completion date: Mar 10, 2025 to Jun 14, 2025
    • Study completion date: Apr 30, 2025 to Jul 30, 2025
    v3
  2. Notable Primary endpoints revised (2)
    • Study title shortened, about 4 words
    v2
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
\- Consecutive eligible patients will be randomized in a 1:1 ratio to esophagogastric complex only myotomy or standard myotomy groups. Randomization is done according to the computer-generated algorithm. A clinical research coordinator will prepare the sealed randomization envelops and will hand over to the operating endoscopists before the beginning of the procedure. Written informed consent will be obtained from all participants. In this study, the participants and the care-provider assessing the clinical response to the POEM procedure at 3months will be blinded to the allocation.
Trial Details
NCT Number NCT06870630
Lead Sponsor Asian Institute of Gastroenterology, India
Conditions
(from sponsor)
Esophageal Diseases
Related terms Esophageal Diseases
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov