POEM- Peroral Endoscopic Myotomy
This study is not yet open for participant recruitment.
Verified January 2012 by Hadassah Medical Organization
Sponsor:
Hadassah Medical Organization
Information provided by (Responsible Party):
Yoav Mintz, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01512719
First received: January 15, 2012
Last updated: January 18, 2012
Last verified: January 2012
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | January 15, 2012 | ||||||||
| Last Updated Date | January 18, 2012 | ||||||||
| Start Date ICMJE | January 2012 | ||||||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Resolution of dysphagia [ Time Frame: up to 6 months postoperatively ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01512719 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | POEM- Peroral Endoscopic Myotomy | ||||||||
| Official Title ICMJE | POEM a Novel Endoscopic Treatment for Achalasia | ||||||||
| Brief Summary | POEM has recently described as an alternative treatment for achalasia in humans. In this procedure the esophageal sphincter is incised through a submucosal tunnel in the esophagus. In this study we aim to perform POEM on achalasia patients. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Achalasia | ||||||||
| Intervention ICMJE | Procedure: POEM
Per Oral Endoscopic Myotomy for achalasia |
||||||||
| Study Arm (s) | Experimental: POEM procedure
Patients with achalasia that undergo POEM
Intervention: Procedure: POEM |
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 25 | ||||||||
| Estimated Completion Date | January 2016 | ||||||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01512719 | ||||||||
| Other Study ID Numbers ICMJE | 040411-HMO-CTIL | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Yoav Mintz, Hadassah Medical Organization | ||||||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Hadassah Medical Organization | ||||||||
| Verification Date | January 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||