Completed

POEMProspective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy (POEM)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from today forward - Prospective
Other
Who is being recruted

Deglutition Disorders+3

+ Digestive System Diseases

+ Esophageal Diseases

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: March 2013
See protocol details

Summary

Principal SponsorUniversity of Florida
Last updated: October 8, 2024
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

Information about the subject's medical history, leading up to the need for an Achalasia treatment, the procedure itself and how the subject does after the procedure, including after the subject gets home, will be collected. This will be done by gathering relevant information from the subject's medical chart and/or by talking with the subject prior to and after the subject's medical procedures. There are no specific study procedures or tests. All information collected is part of the subject's medical care and will be collected even if the subject is not in the study.

NCT01832779
Principal SponsorUniversity of Florida
Last updated: October 8, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

143 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Deglutition DisordersDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesEsophageal Motility DisordersEsophageal Achalasia

Criteria

2 inclusion criteria required to participate
Age 18 years and older
Scheduled to undergo POEM treatment
3 exclusion criteria prevent from participating
Any contraindication to performing endoscopy
Participation in another research protocol that could interfere or influence the outcomes measures of the present study
The subject is unable/unwilling to give informed consent

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Florida Health

Gainesville, United StatesOpen University of Florida Health in Google Maps
CompletedOne Study Center