Ignite Creation Date:
2025-12-25 @ 1:13 AM
Ignite Modification Date:
2026-03-01 @ 12:17 AM
Study NCT ID:
NCT02572193
Status:
UNKNOWN
Last Update Posted:
2016-12-16
First Post:
2015-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Assess the Feasibility of Same Day Discharge Following a POEM Procedure
Sponsor:
McMaster University
Organization:
Study Overview
Official Title:
To Assess the Feasibility of Same Day Discharge Following a POEM Procedure
Status:
UNKNOWN
Status Verified Date:
2016-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POEM2
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: