Completed

POEMA Clinical Study of Per Oral Endoscopic Myotomy (POEM) in Patients Suffering From Achalasia.

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What is being tested

Procedure: Per Oral Endoscopic Myotomy (POEM)

Procedure
Who is being recruted

Deglutition Disorders+3

+ Digestive System Diseases

+ Esophageal Diseases

From 18 to 70 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorMcMaster University
Last updated: September 24, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

All patients will have routine pre-operative EGD, manometry, barium swallow, ph-metry. Equally all patients will undergo Eckardt's and grading systems of symptom severity before and after the intervention. The patients will have a gastro-graffin swallow in the first day after the surgery. Procedure: Under general anesthesia upper endoscopy is performed using a standard single channel gastroscope. Submucosal injection with 10 ml saline with 1% methylen blue at the level of the mid esophagus is initially performed. A small longitudinal submucosal incision is created using a standard needle knife. For a sufficient entry point as well as submucosal tunnel, a dilating balloon is inserted submucosally via the created incision similar to the technique used in standard endoscopic submucosal dissection. The balloon is slightly inflated to allow sufficient entrance of the endoscope. The gastroscope is advanced into the submucosal space and the tunnel is created via needle knife or blunt dissection as appropriate. The tunnel is created distally and is stopped several centimeters beyond the lower esophageal sphincter (LES), which can easily be identified. Using flexible scissors, a triangle tip- or respectively an isolated tip-knife the clearly visible circular muscles are divided starting 4 cm above the LES extending 2 cm beyond the previously identified esophageal border. The longitudinal and serosal layers are left intact. Finally the mucosal entry is closed with standard endoscopic clips. Patients will receive standard postoperative care for surgical myotomy, including long-term follow-up. If for any reason the endoscopic treatment is unable to be completed or infeasible, a standard laparoscopic treatment will be performed.

Principal SponsorMcMaster University
Last updated: September 24, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Deglutition DisordersDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesEsophageal Motility DisordersEsophageal Achalasia

Criteria

4 inclusion criteria required to participate
Able to give written consent

Candidate for a Heller myotomy

No contra-indication to general anesthesia

Their age is >= 18 years and <= 80 years

6 exclusion criteria prevent from participating
Any anatomical esophageal anomaly that in the opinion of the investigator may render the intervention more difficult, such as sigmoid esophagus on the pre-operative barium swallow or hiatal hernia > 2cm

Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure

Body mass index (BMI) > 40

Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The Procedure: per oral endoscopic myotomy (POEM)will be performed on all patients in this single arm study.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

St. Joseph's Healthcare

Hamilton, CanadaOpen St. Joseph's Healthcare in Google Maps
CompletedOne Study Center