Recruiting

Observational StudyGastroparesis Outcome Longitudinal Database Enrolled Numerically

Sponsor:

University of Louisville

Code:

NCT03876288

Conditions

Gastroparesis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

GI Neuromodulation

Immunotherapy

Pyloric Therapies

Study Details

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

Study ID

NCT03876288

Start date

Jan 1, 2013

Status verified date

Jul, 2025

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion:

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

Exclusion:

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

Study Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

GI Neuromodulation

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.

Immunotherapy

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.

Pyloric Therapies

Primary outcome measure

Patient Reported Outcome GI Symptoms [ Time Frame: Change from baseline to one week to one year ]

Central Contacts and Locations

Central contacts

Thomas Abell, MD

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

Locations

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

More Information

Sponsor

University of Louisville

Last update posted

Apr 20, 2026

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2026-04-20.