RECRUITING

Comprehensive Esophageal Diagnostics Study

Conditions

Achalasia lower esophageal sphincter Functional Lumen Imaging Probe Topography anti-fibrosis agents anti-inflammatory agents

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The prospective clinical trial will study muscle fibrosis in relation to lower esophageal sphincter (LES) measurements on Functional Lumen Imaging Probe (FLIP) Topography (the novel technology that utilizes impedance planimetry) after pharmacologic challenge. A better understanding of achalasia will allow intervention at an earlier stage.

Official Title

Comprehensive Assessment of Histopathologic and Physiologic Profile in Esophageal Motility Disorders

Quick Facts

Study Start:2021-03-17

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04641702

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 from October 1, 2020, to September 30, 2024. 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)	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) of questionnaires written in English with some medical terms. These are standardized questionnaires and do not have 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 \[exclusions for Aim 1 only\]

Inclusion Criteria

Exclusion 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 from October 1, 2020, to September 30, 2024.
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)

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) of questionnaires written in English with some medical terms. These are standardized questionnaires and do not have 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 \[exclusions for Aim 1 only\]

Contacts and Locations

Study Contact

Anand Jain, MD

CONTACT

404-778-3184

anand.jain@emory.edu

Principal Investigator

Anand Jain, MD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Emory University Hospital

Atlanta, Georgia, 30322

United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342

United States

Collaborators and Investigators

Sponsor: Emory University

Anand Jain, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-17

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-03-17

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

lower esophageal sphincter
Functional Lumen Imaging Probe Topography
anti-fibrosis agents
anti-inflammatory agents

Additional Relevant MeSH Terms

Achalasia