Clinical Trials Logo

Clinical Trial Summary

This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center setting.

Clinical Trial Description

This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center s

70 patients will be enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the Eckardt symptom score at 3 month after peroral endoscopic myotomy.

Primary outcome:

-Eckhard symptom score 3 month after therapy.

Secondary outcomes:

Lower esophageal sphincter pressure at 3 month after therapy. Reflux symptoms at 3 month after therapy. For this prospective study, inclusion criteria are achalasia, as diagnosed by established methods (contrast fluoroscopy, manometry, esophago-gastro-duodenoscopy) and age greater than 18 years. Previous therapy, such as esophageal surgery or previous myotomy are exclusion criterion.

A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. A electrogenerator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT01405417
Study type Interventional
Source Universitätsklinikum Hamburg-Eppendorf
Status Terminated
Phase N/A
Start date April 2011
Completion date September 2017

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06044155 - redoPOEM : Failure of a First POEM
Completed NCT01399476 - Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia N/A
Recruiting NCT05326113 - The Effect of Physiotherapy on Post POEM Reflux N/A
Recruiting NCT02989883 - Clinical Outcomes of Peroral Endoscopic Myotomy N/A
Recruiting NCT02606578 - Achalasia Patient Reported Outcomes
Enrolling by invitation NCT02770859 - Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository
Recruiting NCT01793922 - POEM Trial: Multi-center Study Comparing Endoscopic Pneumodilation and Per Oral Endoscopic Myotomy (POEM) N/A
Recruiting NCT01302288 - Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia Phase 2
Enrolling by invitation NCT03875365 - Institutional Outcome Data From Per-oral Plication of the Esophagus
Recruiting NCT05905016 - Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders
Completed NCT01692106 - A Clinical Study of Per Oral Endoscopic Myotomy (POEM) in Patients Suffering From Achalasia N/A
Completed NCT01405469 - Endoscopic Peroral Myotomy for Treatment of Achalasia N/A
Completed NCT01402518 - Per-Oral Endoscopic Myotomy
Not yet recruiting NCT00790465 - Efficacy of Dark Chocolate in Achalasia Patients Phase 1/Phase 2
Recruiting NCT01799967 - Minimally Invasive Surgery of the Gastro-esophageal Junction
Terminated NCT00604942 - vMII for Measurement of Oesophageal Bolus Transport and Reflux N/A
Not yet recruiting NCT06042127 - POEM-F for Achalasia International Study N/A
Not yet recruiting NCT05804266 - A Comparison of Underwater Versus Conventional Precoagulation Using Hybrid Knife in Peroral Endoscopic Myotomy for Esophageal Achalasia N/A
Completed NCT04752670 - ConMed Beamer Study
Completed NCT02314741 - Peroral Endoscopic Myotomy (POEM) for Esophageal Motility N/A