NCT05913011

Brief Summary

  • detect the prevalence of IEM among upper git symptom .
  • clarify the role of HRM in diagnosis of refractory upper GIT symptoms.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Status
unknown

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

First Submitted

Initial submission to the registry

June 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

June 12, 2023

Last Update Submit

June 12, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • detect the prevalence of IEM among upper git symptom

    detect the prevalence of IEM among upper git symptom

    Basline

  • clarify the role of HRM in diagnosis of refractory upper GIT symptoms

    clarify the role of HRM in diagnosis of refractory upper GIT symptoms

    Baseline

Eligibility Criteria

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

patient bove the age of 18 years old presented with upper git symptoms

You may qualify if:

  • patient bove the age of 18 years old
  • All patient presented with upper git symptoms

You may not qualify if:

  • Patients \<18 years old 2- patient with known obstructive esophageal disease by endoscopy (i.e. cancer, Stricture) 3- systemic illnesses, scleroderma 4- esophagogastric junction (EGJ) outflow obstruction (mean integrated relaxation pressure ≥15 mmHg).
  • achalasia, 6-Patient who had previouslyundergone esophageal surgery (i.e. antireflux surgery or myotomy) or endoscopic intervention (i.e. transoral fundoplication) were excluded.
  • Patient with atypical (ENT or respiratory) symptoms only . 8-Patient with oropharyngeal dysphagia without associated esophageal symptoms .
  • patient receiving chemotherapy or radiotherapy 10-patient with thyroid disfunction 11- patient with pulber palsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Zhuang QJ, Tan ND, Zhang MY, Chen SF, Luo Y, Xiao YL. Ineffective esophageal motility in Chicago Classification version 4.0 better predicts abnormal acid exposure. Esophagus. 2022 Jan;19(1):197-203. doi: 10.1007/s10388-021-00867-5. Epub 2021 Aug 10.

    PMID: 34378104BACKGROUND
  • Schlottmann F, Patti MG. Primary Esophageal Motility Disorders: Beyond Achalasia. Int J Mol Sci. 2017 Jun 30;18(7):1399. doi: 10.3390/ijms18071399.

    PMID: 28665309BACKGROUND

MeSH Terms

Conditions

Esophageal Motility Disorders

Condition Hierarchy (Ancestors)

Deglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Aya Ahmed Otify, Resident doc

CONTACT

Marwat Mohammed Abokresha, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

June 12, 2023

First Posted

June 22, 2023

Study Start

August 1, 2023

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

June 22, 2023

Record last verified: 2023-06