Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-25 @ 3:49 AM
NCT ID:
NCT04641702
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients, age 18 and above.
2. Evaluated by Emory Digestive Diseases Clinic, Emory Motility Lab, the Emory Endoscopy Unit, or Emory Surgery Department starting October 1, 2020.
3. Has a diagnosis of achalasia or an esophageal motility disorder with confirmed evaluation by one of the following modalities: functional lumen imaging probe (FLIP) or high-resolution esophageal manometry (for Aim 1)
4. Undergoing a diagnostic Functional Lumen Imaging Probe (FLIP) study at Emory University Hospital with anesthesia assistance (for Aim 1)
5. Undergoing Heller myotomy or per oral endoscopic myotomy for the treatment of their esophageal motility disorder (for Aim 2)
Exclusion Criteria:
1. Patients younger than 18 years old
2. Pregnant women
3. Prisoners
4. Non-English speaking - the rationale is that the symptom characterization and outcome data are measured on detailed and fairly lengthy (5-7 pages) questionnaires written in English with some medical terms. These are standardized questionnaires with no short forms available.
5. Cognitively impaired adults unable to provide informed consent
6. Cardiac disease in the form of - arrhythmia requiring ICD or pacemaker, baseline bradycardia with HR \<60 or tachycardia with HR \> 90, congestive heart failure with ejection fraction \<35%, history of myocardial infarction, baseline MAP \<65 or systolic BP \>140, asthma or chronic obstructive pulmonary disease, urinary retention requiring the use of foley catheterization (including intermittent use), narrow-angle glaucoma, myasthenia gravis, GFR \<60 \[exclusions for Aim 1 only\]
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04641702
Study Brief:
Protocol Section:
NCT04641702