Back to resultsEvaluation of a Novel Endoscopic Treatment for Achalasia (POEM)
Primary Purpose
Achalasia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Per-oral Endoscopic Esophagomyotomy (POEM)
Sponsored by
About this trial
This is an interventional other trial for Achalasia focused on measuring dysphagia
Eligibility Criteria
Inclusion Criteria:
o Subjects with a manometric/radiologic diagnosis of primary achalasia; EGD shows no neoplasm
- Ability to undergo general anesthesia
- The subject is > 18 yrs.of age
- Ability to give informed consent
Exclusion Criteria:
o Sigmoid achalasia
- Contraindicated for EGD
- Pregnancy
Sites / Locations
- University Hospitals Case Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
POEM procedure
Arm Description
An endoscopic surgical procedure for achalasia; Per-oral Endoscopic Esophagomyotomy (POEM)will be performed. The POEM procedure will be performed in the operating room under general anesthesia and a scope will then be inserted into your mouth and down your throat and measurements will be taken. With the use of this lighted flexible scope the surgeon will make a small incision in the inner lining of your esophagus (throat), create a tunnel and then cut the muscle between the esophagus (throat) and the stomach. The initial little opening will be closed with a small clip. This procedure will allow easier passage of food into the stomach.
Outcomes
Primary Outcome Measures
The success of the POEM procedure is measured by improved symptoms as compared to pre-op, including the ability to swallow with low incidence of GERD and significantly reduced resting LES pressure
Will assess the outcomes and efficacy of the endoscopic procedure, Per-oral Endoscopic Esophagomyotomy(POEM)in the treatment of achalasia. The patient will be assessed for improvement of their swallowing as assessed on the repeat time barium swallow and increase oral intake without nausea and vomiting.
Secondary Outcome Measures
Full Information
NCT ID
NCT01770249
First Posted
January 15, 2013
Last Updated
April 12, 2022
Sponsor
University Hospitals Cleveland Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01770249
Brief Title
Evaluation of a Novel Endoscopic Treatment for Achalasia
Acronym
POEM
Official Title
Evaluation of a Novel Endoscopic Treatment for Achalasia: Per-oral Endoscopic Esophagomyotomy (POEM)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Cleveland Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is to evaluate outcomes of a less invasive surgical procedure for the treatment of achalasia.
Detailed Description
This study will assess the feasibility and efficacy of a novel endoscopic procedure, Per-oral Endoscopic Esophagomyotomy (POEM)in treating patients with achalasia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia
Keywords
dysphagia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
POEM procedure
Arm Type
Other
Arm Description
An endoscopic surgical procedure for achalasia; Per-oral Endoscopic Esophagomyotomy (POEM)will be performed. The POEM procedure will be performed in the operating room under general anesthesia and a scope will then be inserted into your mouth and down your throat and measurements will be taken. With the use of this lighted flexible scope the surgeon will make a small incision in the inner lining of your esophagus (throat), create a tunnel and then cut the muscle between the esophagus (throat) and the stomach. The initial little opening will be closed with a small clip. This procedure will allow easier passage of food into the stomach.
Intervention Type
Procedure
Intervention Name(s)
Per-oral Endoscopic Esophagomyotomy (POEM)
Other Intervention Name(s)
POEM
Intervention Description
The surgeon is cutting only through the innermost layers of muscles in the esophagus down to the stomach, leaving the outer layer intact.
Primary Outcome Measure Information:
Title
The success of the POEM procedure is measured by improved symptoms as compared to pre-op, including the ability to swallow with low incidence of GERD and significantly reduced resting LES pressure
Description
Will assess the outcomes and efficacy of the endoscopic procedure, Per-oral Endoscopic Esophagomyotomy(POEM)in the treatment of achalasia. The patient will be assessed for improvement of their swallowing as assessed on the repeat time barium swallow and increase oral intake without nausea and vomiting.
Time Frame
Within the first 3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
o Subjects with a manometric/radiologic diagnosis of primary achalasia; EGD shows no neoplasm
Ability to undergo general anesthesia
The subject is > 18 yrs.of age
Ability to give informed consent
Exclusion Criteria:
o Sigmoid achalasia
Contraindicated for EGD
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ponsky Jeffrey, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Novel Endoscopic Treatment for Achalasia
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