Comprehensive Esophageal Diagnostics Study

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04641702
Phase
PHASE4
Status
Recruiting
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Conditions

  • Achalasia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atropine challenge — DRUG
    Atropine challenge. After baseline FLIP, subjects will be administered 15 mcg/kg of intravenous atropine. Two minutes after administration, FLIP will be repeated.
  • Esophageal muscle biopsy — PROCEDURE
    During standard-of-care Heller myotomy, per-oral endoscopic myotomy, or esophagectomy, lower esophageal sphincter and distal esophageal circular muscle samples will be taken with biopsy forceps. 2-3 samples, approximately 2-3 mm each, will be collected.

Study Details

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.

Key Dates

First listed
Nov 24, 2020
Start date
Mar 17, 2021
Status verified
Sep 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Pharmacologic challenge
    Measurement of esophageal response to atropine using functional lumen imaging probe (FLIP)
  • Other: Esophageal muscle biopsy
    Patients with a diagnosis of an esophageal motility disorder who are undergoing Heller myotomy, per-oral endoscopic myotomy, or esophagectomy for treatment of their esophageal motility disorder.
  • No Intervention: Normal esophageal tissues
    Normal esophageal tissues will be obtained from the National Disease Research Interchange (NDRI) donor program to perform muscle biopsy experiments.

Primary Outcome Measure

Degree of lower esophageal sphincter contraction and relaxation [ Time Frame: Two minutes after the study drugs administration ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory Saint Joseph's HospitalAtlantaGeorgia30342-
Emory University HospitalAtlantaGeorgia30322-

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By research site
Emory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital· Atlanta, GA

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