Last reviewed · How we verify

NCT06872255: VADYSMA

Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia

Not yet recruiting NA Last updated 12 March 2025
What this trial tests

NA trial testing Per Oral Endoscopic Myotomy (POEM) in Dysphagia in 30 participants. Not yet recruiting.

Timeline
1 April 2025
Primary endpoint
1 June 2027
1 June 2027

Quick facts

Lead sponsorInstitute for Clinical and Experimental Medicine
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date1 April 2025
Primary completion1 June 2027
Estimated completion1 June 2027
Sites2 locations across Slovakia, Czechia

Drugs / interventions tested

Conditions studied

Sponsor

Institute for Clinical and Experimental Medicine

Who can join

18 and older, any sex, with Dysphagia or Dysphagia, Esophageal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Laparoscopic fundoplication represents the standard antireflux procedure, when conservative measures fail. However, any type of fundoplication may be accompanied by adverse events. Postfundoplication dysphagia (PFD) may hamper results of anti-reflux surgery. Endoscopic pneumatic dilation has been considered as the first line treatment option for persistent PFD. However, studies have not confirmed its effectiveness in this indication. Peroral endoscopic myotomy (POEM) became a standard treatment for the management of esophageal achalasia and moreover has also been assessed in a small cohort of patients with refractory PFD and some patients achieved significant treatment success. We plan to perform a prospective international cohort multicenter study assessing the efficacy of POEM in patients with persistent and severe PFD.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Dysphagia

Currently open trials in the same condition.

Other Institute for Clinical and Experimental Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06872255.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing