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NCT Number: NCT03876288

Gastroparesis Outcome Longitudinal Database Enrolled Numerically

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

Location status: Recruiting

Location contact

Thomas Abell, MD

CONTACT

About this study

  • All patients seen with the Sx of Gp and who were evaluated for diagnosis and/or treatment
  • Including legacy patients who were seen and treated at previous locations (Mississippi, Arkansas, Tennessee) before Kentucky if they were part of a clinical research series.
  • Numbers of patients referred or consulted for Gp Sx who were Drug Refractory.
  • Interventions: GI Neuromodulation with gastric electrical stimulation (GES); Immunotherapy with Intravenous Immunoglobulin; Pyloric therapies such as pyloroplasty, surgical or endoscopic.
  • Data for evaluation by: Sx assessments by whatever scales used; Measures of health related quality of life; Psychological and pain assessments; Gastric emptying texts; Electrical measures including the following: single channel, low resolution and high resolution EGG, plus mucosal and serosal electrograms. High resolution EGG is also called Body Surface Mapping which is frequently measured in our patient population. ; Autonomic measure; Serologic measures; Full thickness biopsies; Measures of outpatient & Emergency Room Visits; Measures of hospitalization; Placement of endoscopic or surgical tubes; Radiological and Surgical procedures; Nutritional assessments; If enrolled in any research protocols for data; Stool biome measures; Metabolic measures; Other morbidity measures; Mortality
  • One of the areas that GOLDEN looks at is High Resolution EGG or Body Surface Mapping (BSM). This specific area included normal control data along with collaborations with the U of Auckland the Temple University. The goals of the BSM portion of GOLDEN are as follows:
  • Goal1: Define Normal Body Surface Gastric Mapping (BSGM) Ranges and Activity Profiles in Adults
  • Goal 2. Define Spatial Patterns of Abnormal Gastric Electrophysiology in a Large Patient Cohort
  • Goal 3: Define Mechanistic Consequences of Retrograde Gastric Slow Wave Activation on Gastric Emptying, Gastric Contractions, and Reflux Events

Work to meet these goals are ongoing

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Gastric electrical stimulation (GES)

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.

Other names: Intravenous immunoglobulin

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.

Other names: Pyloromyotomy

Primary outcomes

  1. Patient Reported Outcome GI Symptoms

    Time frame: Change from baseline to one week to one year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Abell, MD

CONTACT

[email protected]

(502)852-6991

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Acronym: GOLDEN

Important dates

Study start
2013
Primary completion
2028
Study completion
2028
First posted
Mar 15, 2019
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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