Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Johns Hopkins Bloomberg School of Public Health
Study ID
NCT04661215
Status
Recruiting
Apply to this trial

Conditions

  • Diabetic Gastroparesis
  • Gastroparesis
  • Idiopathic Gastric Motility Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Study Details

The overall objective of this study is to determine if there are pyloric sphincter abnormalities in patients with gastroparesis symptoms and determine how prevalent these abnormalities are using tests to assess the pyloric sphincter - endoluminal functional luminal imaging probe (Endoflip™), water load satiety testing (WLST), and high-resolution cutaneous electrogastrography (HR-EGG) using Gastric Alimetry™ System.

Key Dates

Start date
Jan 13, 2026
Status verified
Mar 2026
Primary completion
Mar 30, 2027
Completion
Apr 15, 2027

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Symptoms of gastroparesis
    Participants with symptoms of gastroparesis with minimum Gastroparesis Cardinal Symptom Index (GCSI) score of 2.0
  • Arm: Control participants
    Participants undergoing endoscopy for evaluation but without gastroparesis symptoms or gastroesophageal reflux symptoms. Score 1.0 or less (≤ 1 ) on the GCSI of Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) questionnaire

Primary Outcome Measure

Distensibility of the pylorus [ Time Frame: Baseline ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaScottsdaleArizona85259
Guillermo Barahona, PhD
[email protected]
William Hasler, MD
[email protected]
Jay Paricha, MD (PRINCIPAL_INVESTIGATOR)
William Hasler, MD (PRINCIPAL_INVESTIGATOR)
University of LouisvilleLouisvilleKentucky40202
Bridget Cannon, RN
[email protected]
Thomas Abell, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts GeneralBostonMassachusetts02114
Anna Borodianski
[email protected]
Nir Bar, MD (PRINCIPAL_INVESTIGATOR)
Brad Kuo, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Baha Moshiree, MD
[email protected]
704-355-4593
Kelsey Cuzzuppe
[email protected]
Baha Moshiree, MD (PRINCIPAL_INVESTIGATOR)
Temple UniversityPhiladelphiaPennsylvania19140
Rona T Cooper
[email protected]
215-707-5477
Henry P Parkman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic Arizona· Scottsdale, AZUniversity of Louisville· Louisville, KYMassachusetts General· Boston, MAWake Forest University Health Sciences· Winston-Salem, NCTemple University· Philadelphia, PA

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