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Recruiting NCT02518542

NCT02518542 Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia

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Clinical Trial Summary
NCT ID NCT02518542
Status Recruiting
Phase
Sponsor Medical University of Vienna
Condition Esophageal Achalasia
Study Type INTERVENTIONAL
Enrollment 400 participants
Start Date 2014-06
Primary Completion 2024-06

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Endoscopic intervention AEndoscopic intervention BEndoscopic intervention C

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 400 participants in total. It began in 2014-06 with a primary completion date of 2024-06.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Achalasia is an esophageal motility disorder, which leads to clinical symptoms such as dysphagia, regurgitation, chest pain and consecutive weight loss. Although conventional treatment such as laparoscopic Heller myotomy (LHM) and balloon dilatation (BD) can provide sufficient symptom relief in many patients, both interventions have their individual drawbacks. Additionally, treatment after failed LHM or BD can be challenging and in few might even lead to esophagectomy. Per oral endoscopic myotomy (POEM) and prolonged dilatation (PRD) are two novel endoscopically performed therapeutic options for achalasia and other esophageal motility disorders. Both not only appear to provide good results, when performed as initial treatment but also might be an excellent option after e.g failed LHM. The purpose of this study is to evaluate the long-term efficacy of four different treatment options, such as POEM, PRD with stent-fixation, PD and conventional LHM for achalasia in an individualized treatment setting.

Eligibility Criteria

Inclusion Criteria: * Confirmed diagnosis of achalsia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm Exclusion Criteria: * Contraindication for EGD

Contact & Investigator

Central Contact

Department of Surgery, Medical University of Vienna

✉ sebastian.schoppmann@meduniwien.ac.at; erwin.rieder@meduniwien.ac.at

📞 +43 1 40400

Frequently Asked Questions

Who can join the NCT02518542 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Achalasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT02518542 currently recruiting?

Yes, NCT02518542 is actively recruiting participants. Contact the research team at sebastian.schoppmann@meduniwien.ac.at; erwin.rieder@meduniwien.ac.at for enrollment information.

Where is the NCT02518542 trial being conducted?

This trial is being conducted at Vienna, Austria.

Who is sponsoring the NCT02518542 clinical trial?

NCT02518542 is sponsored by Medical University of Vienna. The trial plans to enroll 400 participants.

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