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GastroparesisPSAGSNCT04661215

Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms

An observational study of Gastroparesis and Idiopathic Gastric Motility Disorder, run by Johns Hopkins Bloomberg School of Public Health at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
How many people
150 participants
Where
5 sitesUnited States
Study dates
13 Jan 2026to 15 Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population will be 150 adult men and women aged 18-85 years, located in the United States, 100 will have symptoms of gastroparesis, and 50 participants in the control group will be patients undergoing upper endoscopy for clinical evaluation of diarrhea, gastrointestinal (GI) bleed, or iron-deficiency anemia, or evaluation for bariatric surgery who do not have upper GI symptoms greater than 1 as assessed by the Gastroparesis Cardinal Symptom Index (GCSI) . Control group participants will not have Gastric Alimetry testing or water load satiety testing.

Who may be able to join

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Male or female, aged 18-85
  • Symptoms of gastroparesis, either diabetic or idiopathic etiology
  • Symptoms of gastroparesis with minimum Gastroparesis Cardinal Symptom Index (GCSI) score of 2.0
  • Individual will have had a prior 4-hour gastric emptying scintigraphy test performed for clinical evaluation within the last 6 months. This gastric emptying test would be done for clinical evaluation and is not part of the research study. From these participants with gastroparesis symptoms, we will include those with delayed gastric emptying as well as those with normal gastric emptying.
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  • Participant must not initiate any new treatments until completion of the study procedures.
  • Willingness to:
  • Stop histamine 2 antagonists, prokinetics (e.g., metoclopramide, erythromycin, domperidone, prucalopride), narcotics, anticholinergics, constipation medications (over the counter laxatives, isotonic polyethylene glycol (PEG) electrolyte preparations (e.g. MiraLax), prescription laxatives (e.g. lubiprostone), proton pump inhibitors, cannabinoids, and cannabidiol (CBD) for 3 days prior to each visit;
  • Abstain from food and water after midnight (at least for 8 hours) before the start of each visit until after the visit.
  • Provision of signed and dated informed consent form
  • Male or female, aged 18 or older
  • Undergoing an upper endoscopy for their clinical evaluation of diarrhea, GI bleed, or iron-deficiency anemia, or evaluation for bariatric surgery.
  • Do not have upper GI symptoms greater than 1 as assessed by the Gastroparesis Cardinal Symptom Index (GCSI) of PAGI-SYM questionnaire.

Who cannot join

  • Prior gut lumen surgery on the esophagus or the stomach, including Nissen fundoplication.
  • Prior surgery on the pylorus (G-POEM, surgical pyloroplasty, surgical pyloromyotomy)
  • Known history of achalasia or esophageal stricture
  • Known history of physiological or mechanical GI obstruction
  • Abnormalities seen on a prior upper endoscopy placing patient at increased risk:
  • Ulcer of the esophagus, stomach, or duodenum
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  • Esophageal varices
  • Individuals at risk for prolonging the endoscopy procedure: severe chronic pulmonary disease, severe food retention in the stomach on endoscopy.
  • Presence of significant gastric or duodenal pathology that could be expected to cause dysmotility (e.g. significant inflammation, infiltrate disorders etc)
  • Individuals with a history of other chronic disease potentially causative of gastrointestinal symptom
  • Acute or chronic renal insufficiency
  • Current eating disorders
  • Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to endoscopic procedures.
  • Individuals with contraindications for endoscopy, including bleeding abnormalities
  • Allergy to eggs preventing sedation with propofol and/or gastric emptying test
  • Significant dysphagia
  • Prior inflammatory bowel disease, Crohn's
  • History of any esophageal/gastric/pyloric injection of botulinum toxin
  • Patients on daily opioid use or >3 day/week use
  • Use of glucagon-like peptide 1 (GLP1) receptor agonists or Sodium-Glucose Transport Protein 2 (SGLT2); Gastric inhibitory polypeptide (GIP)- glucagon-like peptide (GLP) combo

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Laura A Miriel, BS contact

410-955-4165

laura.miriel@jhu.edu

Emily Mitchell, MS, MBA contact

esharke5@jhu.edu

5 sites in 1 country

United States5 sites, 5 recruiting

  • Massachusetts General

    Boston, Massachusetts, 02114

    Nir Bar, MD, nbar@mgh.harvard.edu

    Anna Borodianski, aborodianski@mgh.harvard.edu

    Recruiting

  • University of Louisville

    Louisville, Kentucky, 40202

    Bridget Cannon, RN, Bridget.cannon@louisville.edu

    Thomas Abell, MD

    Recruiting

  • Temple University

    Philadelphia, Pennsylvania, 19140

    Rona T Cooper, 215-707-5477, rona.taylor@temple.edu

    Henry P Parkman, MD

    Recruiting

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

    Guillermo Barahona, PhD, Barahona.Guillermo@mayo.edu

    William Hasler, MD, hasler.william@mayo.edu

    Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

    Baha Moshiree, MD, 704-355-4593, Baha.Moshiree@advocate.org

    Kelsey Cuzzuppe, Kelsey.Cuzzupe@advocatehealth.org

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Study Description: This is a multi-center, prospective, observational study to assess pyloric sphincter abnormalities in patients with symptoms of gastroparesis (both delayed and normal gastric emptying) and control participants without symptoms of gastroparesis using the commercially available, FDA approved endoluminal functional luminal imaging probe (Endoflip™) catheter, which measures diameter, cross-sectional area, pressure, compliance, and distensibility of gastrointestinal sphincter muscles.

This study will assess lower esophageal and pyloric sphincter diameter, CSA, pressure, distensibility, and compliance in patients with symptoms of gastroparesis and delayed gastric emptying, patients with symptoms of gastroparesis but with normal gastric emptying, and normal control participants. The protocol will also include a water load satiety test and use Gastric Alimetry™ System that assesses gastric myoelectrical activity in symptomatic participants but not control participants.

Medical subject headings
Gastroparesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04661215
Study groupRoleWhat they receive
Symptoms of gastroparesisParticipants with symptoms of gastroparesis with minimum Gastroparesis Cardinal Symptom Index (GCSI) score of 2.0
Control participantsParticipants 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distensibility of the pylorus

    Distensibility of the pylorus will be calculated as the median of three measurements (not three different inflations) of distensibility (mm2/mmHg) of the pylorus pressure using the Endoflip balloon catheter at 50 mL volume

    Measured: Baseline

Secondary outcomes (7)

  1. Opening diameter (mm) of the pylorus when 40 mL volume is introduced into the EF325N Endoflip™ measurement catheter.

    diameter (mm) of the pylorus

    Measured: Baseline

  2. Opening diameter (mm) of the pylorus when 50 mL volume is introduced into the EF325N Endoflip™ measurement catheter.

    diameter (mm) of the pylorus

    Measured: Baseline

  3. Cross Sectional Area(mm2) of the pylorus with 40 mL balloon volume

    Cross Sectional Area (mm2) of the pylorus

    Measured: Baseline

  4. Cross Sectional Area(mm2) of the pylorus with 50 mL balloon volume

    Cross Sectional Area (mm2) of the pylorus

    Measured: Baseline

  5. Compliance (mm3/mmHg) of the pylorus with 40 mL balloon volume

    Compliance (mm3/mmHg) of the pylorus

    Measured: Baseline

  6. Compliance (mm3/mmHg) of the pylorus with 50 mL balloon volume

    Compliance (mm3/mmHg) of the pylorus

    Measured: Baseline

  7. Pressure (mmHg) of the pyloric sphincter

    Pressure (mmHg) of the pyloric sphincter

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2020
  2. Study start13 Jan 2026
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion15 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04661215
Sponsor's protocol ID
12 DK PSAGS
Other IDs
U24DK074008, U01DK073974, U01DK074007, U01DK073975, U01DK112193, U01DK073983
Acronym
PSAGS
Status last verified
Mar 2026
First submitted
3 Dec 2020
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Public use complete database will be submitted to the NIDDK Data Repository

Publications

  • Fisher R, Cohen S. Physiological characteristics of the human pyloric sphincter. Gastroenterology. 1973 Jan;64(1):67-75. No abstract available.

    PubMed 4683856

  • Parkman HP, Hasler WL, Fisher RS; American Gastroenterological Association. American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis. Gastroenterology. 2004 Nov;127(5):1592-622. doi: 10.1053/j.gastro.2004.09.055.

    PubMed 15521026

  • Desipio J, Friedenberg FK, Korimilli A, Richter JE, Parkman HP, Fisher RS. High-resolution solid-state manometry of the antropyloroduodenal region. Neurogastroenterol Motil. 2007 Mar;19(3):188-95. doi: 10.1111/j.1365-2982.2006.00866.x.

    PubMed 17300288

  • Mearin F, Camilleri M, Malagelada JR. Pyloric dysfunction in diabetics with recurrent nausea and vomiting. Gastroenterology. 1986 Jun;90(6):1919-25. doi: 10.1016/0016-5085(86)90262-3.

    PubMed 3699409

Questions about this trial

What is this clinical trial studying?

An observational study of Gastroparesis and Idiopathic Gastric Motility Disorder, run by Johns Hopkins Bloomberg School of Public Health at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laura A Miriel, BS (410-955-4165, laura.miriel@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distensibility of the pylorus (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04661215, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.

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