Gastroparesis Outcome Longitudinal Database Enrolled Numerically

NCT03876288 | Recruiting FDA Device

• 1 other identifier: 20.0697
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

GOLDEN is a longitudinal database of patients with the symptoms (Sx) of gastroparesis (Gp) who were seen and recorded at the University of Louisville from 2012 and is ongoing. Patients are enrolled and followed by sequential numbers and may include legacy patients seen at other centers by some of the same team and who are reported as part of the series. Outcome relate to patients Sx, survival, quality of life and other measures as detailed below, over time. The study tracks patients regardless of treatment but specifically focuses on GI Neuromodulation (gastric electrical stimulation - GES), Immunotherapy (IVIG), and Pyloric therapies (pyloroplasty, endoscopic). If treatments were administered GOLDEN allows for examination and stratification of outcome by groups both at baseline and at follow up.

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Patient Reported Outcome GI Symptoms

  The primary outcome measures are patient symptoms via the traditional gastroparesis patient reported outcome scale. It uses a 0-4 scale from none to worse on GI Symptoms; for example: Nausea,Vomiting, Anorexia/Early Satiety, Bloating/distension, Abdominal Pain. Scored as each item plus a total that is the sum of the individual scales.The five Sx subscales of 0-4 each are summed for a total score range 0-20

  Change from baseline to one week to one year

Study Arms (1)

People presenting with the Sx of Gp

People presenting with the symptoms of gastroparesis. The three main interventions are GI neuromodulation, immunotherapy, and pyloric therapies.

Device: GI Neuromodulation; Drug: Immunotherapy; Procedure: Pyloric Therapies

Interventions

GI Neuromodulation DEVICE

The investigators would include follow up with: No treatment; temp GES only; temp followed by Perm GES; Other device therapies; specific pain therapies; drug therapies, including investigational drugs; immunotherapy; pyloric therapies; psychological/behavioral therapies; nutritional support; radiological and surgical therapies; infection rates related to procedures; if enrolled in any therapy research trials; morbidity and mortality after specific therapies; other treatments used.

Also known as: Gastric electrical stimulation (GES)

People presenting with the Sx of Gp

Immunotherapy DRUG

The investigators would include follow up with: No treatment; temp gastric electrical stimulation (GES) only; temp followed by Perm GES; Other device therapies; specific pain therapies; drug therapies, including investigational drugs; immunotherapy; pyloric therapies; psychological/behavioral therapies; nutritional support; radiological and surgical therapies; infection rates related to procedures; if enrolled in any therapy research trials; morbidity and mortality after specific therapies; other treatments used.

Also known as: Intravenous immunoglobulin

People presenting with the Sx of Gp

Pyloric Therapies PROCEDURE

The investigators would include follow up with: No treatment; temp gastric electrical stimulation (GES) only; temp followed by Perm GES; Other device therapies; specific pain therapies; drug therapies, including investigational drugs; immunotherapy; pyloric therapies; psychological/behavioral therapies; nutritional support; radiological and surgical therapies; infection rates related to procedures; if enrolled in any therapy research trials; morbidity and mortality after specific therapies; other treatments used.

Also known as: Pyloromyotomy

People presenting with the Sx of Gp

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients seen

You may qualify if:

• Patients with the symptoms (Sx) of drug refractory gastroparesis
• Disordered nutrition by standardized assessment
• Ability to assess current symptom status
• Ability to measure other medical conditions

You may not qualify if:

• Anatomic obstruction of the GI Tract
• Pregnancy
• Inability of patient or guardian to sign informed consent, if needed
• Psychiatric disorders precluding assessment and treatment of the patient's GI condition

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Related Publications (3)

• Kasem F, Naing LY, Mathur P, McElmurray L, Moppins C, Daniels MW, Stocker A, Abell TL, Omer E. Patients With Gastroparesis Symptoms After Gastric Electrical Stimulation With and Without Tube Feedings. Neuromodulation. 2025 Nov 26:S1094-7159(25)00687-7. doi: 10.1016/j.neurom.2025.07.008. Online ahead of print.

  PMID: 41307525 DERIVED

• Kochar T, Cai W, Guardiola JJ, Mathur P, Hassan H, Atassi H, Stocker A, Hughes M, McElmurray L, Pinkston C, Abell TL. Nutritional Assessment in Patients after Gastric Electrical Stimulation (GES). J Clin Gastroenterol. 2024 Feb 1;58(2):136-142. doi: 10.1097/MCG.0000000000001826.

  PMID: 36626193 DERIVED

• Shine A, Mathur P, Ahmed S, Ramos S, McElmurray L, Stocker A, Pinkston C, Abell TL. Low-Resolution Electrogastrogram at Baseline and Response to Temporary Gastric Electrical Stimulation-A Comparison of Cutaneous With Mucosal Recordings. Neuromodulation. 2022 Dec;25(8):1150-1159. doi: 10.1016/j.neurom.2021.12.008. Epub 2022 Feb 17.

  PMID: 35183451 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Laboratory testing, both clinical and research

MeSH Terms

Conditions

Gastroparesis

Interventions

Immunotherapy; Immunoglobulins, Intravenous; Pyloromyotomy

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Digestive System Surgical Procedures; Surgical Procedures, Operative; Gastrectomy; Myotomy

Study Officials

• Thomas Abell, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Abell, MD

CONTACT

(502)852-6991; thomas.abell@louisville.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Arthur M Schoen MD Chair in Gastroenterology

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: March 15, 2019
• Study Start: January 1, 2013
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2025-07

Locations

US (1)