Recruiting

Pyloric Sphincter Assessment

Sponsor:

Johns Hopkins Bloomberg School of Public Health

Code:

NCT04661215

Conditions

Gastroparesis

Idiopathic Gastric Motility Disorder

Diabetic Gastroparesis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief 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 (WLST), and high-resolution cutaneous electrogastrography (HR-EGG) using Gastric Alimetry™ System.

Conditions

Gastroparesis

Idiopathic Gastric Motility Disorder

Diabetic Gastroparesis

Study ID

NCT04661215

Start date

Jan 13, 2026

Status verified date

Mar, 2026

Completion date

Apr 15, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria FOR SYMPTOMATIC PARTICIPANTS:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged 18-85
4. Symptoms of gastroparesis, either diabetic or idiopathic etiology
5. Symptoms of gastroparesis with minimum Gastroparesis Cardinal Symptom Index (GCSI) score of 2.0
6. 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.
7. Participant must not initiate any new treatments until completion of the study procedures.
8. Willingness to:

1. 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;
2. Abstain from food and water after midnight (at least for 8 hours) before the start of each visit until after the visit.

INCLUSION CRITERIA FOR CONTROL PARTICIPANTS

1. Provision of signed and dated informed consent form
2. Male or female, aged 18 or older
3. Undergoing an upper endoscopy for their clinical evaluation of diarrhea, GI bleed, or iron-deficiency anemia, or evaluation for bariatric surgery.
4. Do not have upper GI symptoms greater than 1 as assessed by the Gastroparesis Cardinal Symptom Index (GCSI) of PAGI-SYM questionnaire.

EXCLUSION CRITERIA:

1. Prior gut lumen surgery on the esophagus or the stomach, including Nissen fundoplication.
2. Prior surgery on the pylorus (G-POEM, surgical pyloroplasty, surgical pyloromyotomy)
3. Known history of achalasia or esophageal stricture
4. Known history of physiological or mechanical GI obstruction
5. Abnormalities seen on a prior upper endoscopy placing patient at increased risk:

  • Ulcer of the esophagus, stomach, or duodenum
  • Esophageal varices
6. Individuals at risk for prolonging the endoscopy procedure: severe chronic pulmonary disease, severe food retention in the stomach on endoscopy.
7. Presence of significant gastric or duodenal pathology that could be expected to cause dysmotility (e.g. significant inflammation, infiltrate disorders etc)
8. Individuals with a history of other chronic disease potentially causative of gastrointestinal symptom
9. Acute or chronic renal insufficiency
10. Current eating disorders
11. Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to endoscopic procedures.
12. Individuals with contraindications for endoscopy, including bleeding abnormalities
13. Allergy to eggs preventing sedation with propofol and/or gastric emptying test
14. Significant dysphagia
15. Prior inflammatory bowel disease, Crohn's
16. History of any esophageal/gastric/pyloric injection of botulinum toxin
17. Patients on daily opioid use or >3 day/week use
18. 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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Symptoms of gastroparesis

Participants with symptoms of gastroparesis with minimum Gastroparesis Cardinal Symptom Index (GCSI) score of 2.0

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 and Locations

Central contacts

Emily Mitchell, MS, MBA

esharke5@jhu.edu

Locations

Mayo Clinic Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Guillermo Barahona, PhD

Barahona.Guillermo@mayo.edu

William Hasler, MD

hasler.william@mayo.edu

Principal Investigator:

Jay Paricha, MD

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Principal Investigator:

Thomas Abell, MD

Massachusetts General

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Nir Bar, MD

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Principal Investigator:

Baha Moshiree, MD

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Principal Investigator:

Henry P Parkman, MD

More Information

Sponsor

Johns Hopkins Bloomberg School of Public Health

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health on 2026-04-03.