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Gastroparesis Outcome Longitudinal Database Enrolled Numerically (GOLDEN)

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ClinicalTrials.gov Identifier: NCT03876288
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Abell, University of Louisville

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, regardless of whether any treatment was given or not. If treatments were administered GOLDEN allows for examination and stratification of outcome by groups both at baseline and at follow up.

Condition or disease Intervention/treatment
Gastroparesis Device: GI Neuromodulation Drug: Immunotherapy Procedure: Pyloric Therapies

Detailed Description:
  1. All patients seen with the Sx of Gp and who were evaluated for diagnosis and/or treatment
  2. 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.
  3. Numbers of patients referred or consulted for Gp Sx who were Drug Refractory.
  4. Interventions: GI Neuromodulation with gastric electrical stimulation (GES); Immunotherapy with Intravenous Immunoglobulin; Pyloric therapies such as pyloroplasty, surgical or endoscopic.
  5. 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; 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

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Gastroparesis Outcome Longitudinal Database Enrolled Numerically
Actual Study Start Date : January 1, 2013
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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 Name: Gastric electrical stimulation (GES)

Drug: 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.
Other Name: Intravenous immunoglobulin

Procedure: Pyloric Therapies
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 Name: Pyloromyotomy




Primary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Laboratory testing, both clinical and research


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients seen
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876288


Contacts
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Contact: Thomas Abell, MD (502)852-6991 thomas.abell@louisville.edu

Locations
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United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Thomas Abell, MD         
Sponsors and Collaborators
University of Louisville
Investigators
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Principal Investigator: Thomas Abell, MD University of Louisville

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Responsible Party: Thomas Abell, The Arthur M Schoen MD Chair in Gastroenterology, University of Louisville
ClinicalTrials.gov Identifier: NCT03876288     History of Changes
Other Study ID Numbers: 13.0020
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Immunologic Factors
Immunoglobulins
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Physiological Effects of Drugs