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Clinical Trials/NL-OMON50756
NL-OMON50756
Recruiting
Not Applicable

Pneumodilation versus Per-Oral Endoscopic Myotomy in Achalasia patients with recurrent symptoms after Laparoscopic Heller Myotomy trial - POEMA 2

Academisch Medisch Centrum0 sites45 target enrollmentTBD
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ConditionsAchalasiaoesophageal motiliy disorder10017977

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Achalasia
Sponsor
Academisch Medisch Centrum
Enrollment
45
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Presence of achalasia as shown on oesophageal manometry at least once
  • •Previous Heller myotomy
  • •Eckardt score \> 3
  • •Significant stasis (stasis of \>\=2 cm on barium oesophagogram after two minutes)
  • •Age between 18\-80 years
  • •Signed written informed consent

Exclusion Criteria

  • •Previous pneumodilations after the Heller myotomy (pneumodilations before the
  • •Heller myotomy are allowed)
  • •Previous (attempt at) POEM
  • •Previous surgery of the stomach or oesophagus, except Heller myotomy
  • •Known coagulopathy
  • •Presence of liver cirrhosis and/or oesophageal varices
  • •Presence of eosinophilic oesophagitis
  • •Pregnancy at time of treatment
  • •Presence of a stricture of the oesophagus
  • •Presence of malignant or premalignant oesophageal lesions

Outcomes

Primary Outcomes

Not specified

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