Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-31 @ 7:06 PM
Study NCT ID:
NCT01742494
Status:
UNKNOWN
Last Update Posted:
2012-12-05
First Post:
2012-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Study Overview
Official Title:
Peroral Endoscopic Myotomy for Esophageal Achalasia: Randomized Comparison of Water-Jet Assisted Versus Conventional Dissection Technique
Status:
UNKNOWN
Status Verified Date:
2012-12
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:
None
Brief Summary:
Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical modifications have been proposed but have not yet been tested in randomized trials.
Detailed Description:
Objective: To evaluate efficacy and safety of water-jet assisted POEM (WJ) versus the conventional technique (C).
Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM were randomized to either the use of Erbe Hybrid knife (WJ group) or the conventional technique using injection and triangle tip knife interchangeably (C group).
Main outcome measurements: Procedure time in both groups; secondary outcomes were clinical efficacy and safety (bleeding complications, pneumothorax or pleural effusion requiring intervention)
Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM were randomized to either the use of Erbe Hybrid knife (WJ group) or the conventional technique using injection and triangle tip knife interchangeably (C group).
Main outcome measurements: Procedure time in both groups; secondary outcomes were clinical efficacy and safety (bleeding complications, pneumothorax or pleural effusion requiring intervention)
Study Oversight
Has Oversight DMC:
True
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?: