NCT07156357

Brief Summary

Evaluating swallowing food with surface electromyography (EMG) machine in patients with Eosinophilic Esophagitis

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
13mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Aug 2025Jun 2027

Study Start

First participant enrolled

August 4, 2025

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

August 15, 2025

Last Update Submit

September 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Preparatory phase time

    Comparison of preparatory phase between cohorts

    Through study completion an average of 2 days

Secondary Outcomes (1)

  • Time difference in swallow initiation

    Through study completion an average of 2 days

Study Arms (2)

Controls

Subjects who can swallow normally

Diagnostic Test: Surface ElectromyographyDiagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing

Eosinophilic Esophagitis

Subjects with Eosinophilic Esophagitis

Diagnostic Test: Surface ElectromyographyDiagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing

Interventions

Tests performed to evaluate swallowing function

ControlsEosinophilic Esophagitis

Assessment of swallowing function

ControlsEosinophilic Esophagitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We will recruit patients with EoE seen in the esophageal clinic. Controls will be recruited by monitoring for patients that present for video swallow with speech language pathology and have a normal video swallow.

You may qualify if:

  • Controls
  • Normal video swallow or score of 0 for dysphagia on ESSAI questionnaire
  • absence of dysphagia
  • age \>18 EoE participants
  • Documentation of EoE diagnosis by histologic criteria,
  • \>15 eos/hpf on most recent esophageal biopsy
  • age \>18

You may not qualify if:

  • Abnormal baseline video swallow
  • lack of MSK coordination to eat test meal
  • underlying neuromuscular disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Electromyography

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

ElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyography

Study Officials

  • Karthik Ravi, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Alexander, MD

CONTACT

Mariah Robran, CCRP

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 15, 2025

First Posted

September 5, 2025

Study Start

August 4, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations