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

NCT06870630 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2025-06-10

No results posted yet for this study

Summary

\- 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.

Conditions

  • Esophageal Diseases

Interventions

DEVICE

Per oral endoscopy myotomy

Poem procedure is meant for cutting of circular and longitudinal muscle fibers in esophagus to reduce the symptoms of dysphagia, regurgitation and chestpain, weight loss.

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • Mohan Dr Ramchandani, MBBS MD · AIG Hospitals

  • Zaheer Dr Nabi, MBBS MD · AIG Hospitals

  • Pradev Dr Inovolu, MBBS MD · AIG Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2025-06-14
Completion
2025-07-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06870630 on ClinicalTrials.gov