NCT03876288 Gastroparesis Outcome Longitudinal Database Enrolled Numerically
| NCT ID | NCT03876288 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Louisville |
| Condition | Gastroparesis |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2013-01-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2013-01-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Thomas Abell, MD
PRINCIPAL INVESTIGATOR
University of Louisville
Frequently Asked Questions
Who can join the NCT03876288 clinical trial?
This trial is open to participants of all sexes, studying Gastroparesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03876288 currently recruiting?
Yes, NCT03876288 is actively recruiting participants. Contact the research team at thomas.abell@louisville.edu for enrollment information.
Where is the NCT03876288 trial being conducted?
This trial is being conducted at Louisville, United States.
Who is sponsoring the NCT03876288 clinical trial?
NCT03876288 is sponsored by University of Louisville. The principal investigator is Thomas Abell, MD at University of Louisville. The trial plans to enroll 3,000 participants.