Peroral Endoscopic Myotomy for the Treatment of Achalasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic procedure for achalasia.
- Who it may be relevant to
- Registry conditions: Achalasia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Peroral Endoscopic Myotomy for the Treatment of Achalasia: A Single-center Registry
Overview
There will be a retrospective chart review for patients who underwent endoscopic procedures and POEM from 06/2016 - 01/2019 \& a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02/2019 - 06/2021
Detailed description
Subjects will undergo no additional tests and procedures as part of this study. All data will be collected from patient's electronic health records (EHR) of the hospital In addition; a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02/2019 - 06/2021. All the subjects enrolled in prospective chart review will be first consented for their study participation. Subjects will undergo a clinically indicated endoscopic procedure and POEM and subsequent follow-up clinical visits as part of their standard medical care. All procedures, barring research activities such as consenting and data collection from Electronic Health Records, will be either clinically indicated and/or standard of care.
* Each patient in the study will be assigned a Case ID number to de-identify their personal health information during data collection * The Case ID number connecting the patient to the personal health information will be in an encrypted electronic file on a computer that can only be accessed by study members at MDMC. * A procedure report and outpatient clinical records for each subject's POEM procedure will be used to record each patient's data for the registry * That data will only be shared by members of the study (PIs, research coordinator) who require it for conducting of data collection/interpretation
"Disclaimer: Any cost associated with the procedures stated herein will be billed directly to you or to your insurance (as applicable)."
Interventions
- Procedure Endoscopic procedure for achalasia
POEM procedure will have a high technical feasibility, with effective clinical resolution of symptoms both in the short and long term.
Primary outcome measures
- Decrease or no symptoms of chest pain [Time frame: upto 180 days]
Eligibility criteria
Inclusion criteria
- Any discharged patient who has undergone clinically indicated and/or standard of care POEM for the treatment of Achalasia from 6/2016 to 6/2021.
- Above or equal to 18 years of age
Exclusion criteria
- Any patient who has not undergone POEM for the treatment of Achalasia.
- Below 18 years of age
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Methodist Dallas Medical Center — Dallas
Identifiers
NCT: NCT04640753 · 031.GID.2018.D