Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring
ConditionDysphagia, Esophageal
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorIndiana University
About this trial
Comparison of manometry measurements and EndoFlip Balloon measurements in patients with dysphagia and a known esophageal diagnosis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients who presented to GI Motility Lab at IU University Hospital for esophageal manometry-impedance and/or EndoFLIP
Disqualifiers
Age <18 yrs old
Unable to communicate verbally with the staff
Trial 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
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Manometry
Diagnostic testTransnasal Esophageal manometry and Endoflip Balloon distensibility
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Dysphagia1 intervention
Trial outcomes
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.
Time frame
5 yearsSecondary outcomes
1
Correlation between endoflip parameters and gastric scintigraphy
Correlate distensibility data (cross-sectional area, pressure, distensibility index) with severity of delayed gastric emptying in patients with gastroparesis
Time frame
5 years2
Correlation between endoflip parameters and symptom severity
Correlate distensibility data (cross-sectional area, pressure, distensibility index) with severity of gastroparesis symptoms by Patient Assessment GI-Ssymptoms (PAGI-SYM)
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov