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The Role That Peroral Endoscopic Myotomy (POEM) Could Play in the Treatment of Achalasia (POEM)
This study has been completed.
Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
David A. Katzka, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01584635
First received: January 12, 2012
Last updated: October 27, 2016
Last verified: October 2016
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Purpose
Based on the work of the Doctors at the Mayo Clinic Rochester, a new technique for a less invasive treatment for Achalasia has been developed.
The purpose of this study is to decide the role this less invasive treatment (Peroral Endoscopic Myotomy) has in the treatment of patient's with achalasia.
| Condition | Intervention |
|---|---|
| Achalasia | Procedure: Peroral Endoscopic Myotomy a less invasive treatment for Achalasia |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Peroral Endoscopic Myotomy (POEM) for Treatment of Achalasia |
Resource links provided by NLM:
Further study details as provided by David A. Katzka, Mayo Clinic:
Primary Outcome Measures:
- Number of participants with adverse events [ Time Frame: 5 years post surgery ]Patients in this study, undergoing the Peroral Endoscopic Myotomy treatment for Achalasia, will be accessed at 1 month, 6 months, at 1-2-3-4 and year 5 post surgery. We will measure outcomes by number of adverse events, Eckardt symptom score, barium esophagram, and manometry studies.
Secondary Outcome Measures:
- Eckardt symptom score [ Time Frame: 5 years ]By following participants regularly and closely both by symptomatic and objective criteria, we will be able to determine factors that predict response to the POEMS procedure.
| Enrollment: | 20 |
| Study Start Date: | January 2012 |
| Study Completion Date: | January 2016 |
| Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Peroral Endoscopic Myotomy (POEM)
Peroral Endoscopic Myotomy- a less invasive treatment for patients with Achalasia
|
Procedure: Peroral Endoscopic Myotomy a less invasive treatment for Achalasia
In this study we will follow patients undergoing Peroral Endoscopic Myotomy at 1 and 6 months post surgery,1,2,3,4,and 5 years post surgery with esophageal high resolution Manometry and a Barium Esophagram when it is not standard of care. We will have you fill out a symptom questionnaire at each visit
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients between the ages of 18 and 80 with achalasia diagnosed by a combination of compatible symptoms, barium esophagography and high resolution manometry.
Exclusion Criteria:
- Patients who are poor surgical risks, have had previous treatment for achalasia or esophageal or gastric surgery, have an epiphrenic diverticulum or are unwilling to be followed in the protocol.
- Female patients are eligible if they are NOT pregnant or lactating AND ne of the following criteria is met:
- The patient is surgically sterile (by means of hysterectomy/bilateral tubal ligation)
- The patient is at least one year postmenopausal (no menses for 12 months).
- The patient is using a highly effective method of contraception, if childbearing potential, AND has a negative urine human chorionic gonadotropin beta subunit (ß HCG) pregnancy test result during Screening, and prior to trial drug administration.
- Highly effective methods of birth control are defined as those which result in a low failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
- Withdrawal, single- or double barrier methods (including condoms) and rhythm methods are NOT ACCEPTABLE methods of contraception for the purposes of this clinical trial due to the high incidence of contraceptive failures with these methods.
- Vulnerable populations, such as those with diminished mental acuity, will be excluded.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584635
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584635
Locations
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
Sponsors and Collaborators
Mayo Clinic
Investigators
| Principal Investigator: | David Katzka, MD | Mayo Clinic |
More Information
| Responsible Party: | David A. Katzka, Principal Investigator, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01584635 History of Changes |
| Other Study ID Numbers: |
11-005252 |
| Study First Received: | January 12, 2012 |
| Last Updated: | October 27, 2016 |
Keywords provided by David A. Katzka, Mayo Clinic:
|
Less invasive treatment for Achalasia |
Additional relevant MeSH terms:
|
Esophageal Achalasia Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on September 21, 2017