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
    Esophageal muscle biopsy. During standard-of-care Heller myotomy or per-oral endoscopic myotomy, 5mm of lower esophageal sphincter and distal esophageal circular muscle will be collected via biopsy forceps.

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

Start date
Mar 17, 2021
Status verified
Nov 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pharmacologic challenge
    Measurement of esophageal response to atropine using functional lumen imaging probe (FLIP)

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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