NCT04503785

Brief Summary

Comparison of manometry measurements and EndoFlip Balloon measurements in patients with dysphagia and a known esophageal diagnosis

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

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 Start

First participant enrolled

January 17, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2018

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

9 years

First QC Date

March 22, 2018

Last Update Submit

August 14, 2024

Conditions

Dysphagia, Esophageal

Outcome Measures

Primary Outcomes (1)

  • Endoflip parameters for gastroparesis

    Compare the distensibility index (mm2/mmHg) of the pylorus at 50 ml distension in patients with postsurgical gastroparesis and compare to patients with idiopathic and diabetic gastroparesis.

    5 years

Secondary Outcomes (2)

  • Correlation between endoflip parameters and gastric scintigraphy

    5 years

  • Correlation between endoflip parameters and symptom severity

    5 years

Study Arms (1)

Dysphagia

Patients with Esophageal dysphagia

Diagnostic Test: Manometry

Interventions

ManometryDIAGNOSTIC_TEST

Transnasal Esophageal manometry and Endoflip Balloon distensibility

Also known as: Endoflip
Dysphagia

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study subjects will be recruited from patients who were referred by their physicians to the GI Motility Lab at IU University Hospital for esophageal manometry-impedance and/or EndoFLIP

You may qualify if:

  • All patients who presented to GI Motility Lab at IU University Hospital for esophageal manometry-impedance and/or EndoFLIP

You may not qualify if:

  • Age \<18 yrs old
  • Unable to communicate verbally with the staff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • John M Wo, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lainna Cohen

CONTACT

larcohen@iu.edu

Maureen Schilling

CONTACT

maschi@iu.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Motility and Neurogastroenterology Unit

Study Record Dates

First Submitted

March 22, 2018

First Posted

August 7, 2020

Study Start

January 17, 2017

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

August 15, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)