An interventional study of POEM in Esophageal Achalasia, sponsored by McMaster University. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-12-16.
Sponsored by McMaster University · Not applicable, Interventional, and Treatment
This is a study of an investigational surgical procedure for the treatment of achalasia the inability of smooth muscle to move food down the esophagus. A new procedure, called the POEM procedure (per oral endoscopic myotomy) has been developed for achalasia. This study is being performed to determine if patients can go home on the same day as their procedure.
This is a study of an investigational surgical procedure for the treatment of achalasia the inability of smooth muscle to move food down the esophagus.
Standard care for participants includes Heller Myotomy, a laparoscopic procedure that includes cutting the muscle layers in the lower esophageal sphincter (LES) the valve at the bottom of your esophagus. A second procedure is then required to prevent reflux (acid entering the esophagus from the stomach) called fundoplication. Patients with the Heller myotomy will typically stay overnight in hospital. A new procedure, called the POEM procedure (per oral endoscopic myotomy) has been developed for achalasia. This procedure uses endoscopy and no incisions to cut one muscle layer. A fundoplication is not required with this method. This study treatment works by entering the surgical area through the mouth and then making an incision (cut) through the esophagus and placing flexible instruments along the outside of the esophagus and down to the LES through a tunnel. The instruments used in this procedure are standard endoscopic instruments that will be provided by one of the leading endoscopic instrument manufacturers, Olympus. The investigators have recently completed a small study showing this procedure is safe and feasible. One observation from this pilot study was that most patients had no pain and didn't need any pain medications. Due to this reason, the investigators think patient's may go home on the same day as their procedure.
140 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 93 interventional studies indexed under Esophageal Achalasia.
Browse Esophageal Achalasia studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants must meet ALL of the following inclusion criteria:
Exclusion Criteria:
Participants who meet any of the following criteria at the time of the baseline visit are NOT eligible to be enrolled in this study:
POEM procedure
Procedure: POEM
To determine the feasibility of same-day discharge following a POEM procedure
percent of patients leaving on post-operative day 0
Time frame: 1 year
percent of patients who experience post-operative reflux
Time frame: 1 year
This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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