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Comprehensive Esophageal Diagnostics Study

StatusRecruiting
PhasePhase 4
Started2021-03-17
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 26 months later Sep 30, 2026 → Dec 2028
See other at-risk trials from Emory University

Amendment history

2026-09-17
Trial arms changed: 1 → 3
Primary completion pushed: 2026-09-30 → 2028-12
Completion pushed: 2026-12-31 → 2028-12
2025-11-05
Study Identification, Study Status, Eligibility v9
Primary completion date2025-10-30→2026-09-30
Completion date2025-12-31→2026-12-31
Eligibility criteria-30 characters
[...] Lab, the Emory Endoscopy Unit, or Emory Surgery Department fromstarting October 1, 2020, to September 30, 2024. Has a diagnosis of achalasia or an esophageal motility dis [...] ata are measured on detailed and fairly lengthy (5-7 pages) of questionnaires written in English with some medical terms. These are standardized questionnaires andwith do not haveno short forms available. Cognitively impaired adults unable t [...]
2025-07-14
Study Status v8
Re-verified, no change to tracked fields
2024-07-11
Study Status v7
Primary completion date2024-09→2025-10-30
Completion date2024-12→2025-12-31
2024-04-03
Study Status, Arms and Interventions, Eligibility, IPDSharing v6
Primary completion date2023-11→2024-09
Completion date2023-11→2024-12
Eligibility criteria+9 characters
[...] scopy Unit, or Emory Surgery Department from October 1, 2020, to September 30, 20232024. Has a diagnosis of achalasia or an esophageal motility dis [...] ng modalities: functional lumen imaging probe (FLIP) or high-resolution esophageal manometry (for Aim 1) Undergoing a dia [...] Undergoing Heller myotomy or per oral endoscopic myotomy for the treatment of their esophageal motility disorder (for Aim 2) [...] 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]
Show 5 earlier versions
2023-03-14
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v5
Study sites1→2
Collaborators+72 characters
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2022-03-09
Suspended→Recruiting Study Status, Contacts/Locations v4
Trial statusSuspended→Recruiting
Reason stoppedStudy is temporarily suspended pending personnel changes and continuing review IRB approval, etc.→not stated
Study sitesdetails revised at 1 of 1 site
2022-01-19
Recruiting→Suspended Study Status, Contacts/Locations v3
Trial statusRecruiting→Suspended
Reason stoppednot stated→Study is temporarily suspended pending personnel changes and continuing review IRB approval, etc.
Study sitesdetails revised at 1 of 1 site
2021-08-17
Study Status, Study Description, Arms and Interventions, Outcome Measures v2
Start dateestimated 2021-03→confirmed 2021-03-17
InterventionsAtropine challenge (Drug), Edrophonium challenge (Drug), Esophageal muscle biopsy (Procedure)→Atropine challenge (Drug), Esophageal muscle biopsy (Procedure)
Study description-188 characters
[...] ve clinical trial will study muscle fibrosis in relation to lower esophageal sphincter (LES) measurements on Functional Lumen Imaging Probe (FLIP) Topog [...] utilizes impedance planimetry) after pharmacologic challenge designed to augment and remove the active component (edrophonium and atropine administration respectively) of LES tone. A better understanding of achalasia will allow intervention at an earlier stage, potentially with anti-fibrosis agents or anti-inflammatory agents and improve treatment outcomes.
2021-03-05
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2020-12→2021-03
Study sitesdetails revised at 1 of 1 site
2020-11-18
Original filing
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.
Trial Details
NCT Number NCT04641702
Lead Sponsor Emory University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Achalasia
Enrollment 80 participants
Start Date 2021-03-17
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-16