Gastroparesis Outcome Longitudinal Database Enrolled Numerically

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT03876288
Status
Recruiting
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Conditions

  • Gastroparesis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 1, 2013
Status verified
Jul 2025
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of LouisvilleLouisvilleKentucky40202
Thomas Abell, MD

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By research site
University of Louisville· Louisville, KY

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