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NCT03123809 · ClinicalTrials.gov registry record · NA
Gastric Electrical Stimulation (GES) and Pyloroplasty for the Treatment of Gastroparesis
A NA study, sponsored by Texas Tech University Health Sciences Center, El Paso.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
NCT03123809 is a NA study that has completed, run by Texas Tech University Health Sciences Center, El Paso. The registered enrollment target is 44 participants.
The verdict
NCT03123809, a NA study, has completed, sponsored by Texas Tech University Health Sciences Center, El Paso.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
Study Summary
Gastroparesis (GP) is describing a condition when stomach does not empty as fast as it should. This fact creates the situation, when food stays in the stomach for a long time and it causes symptoms of nausea, vomiting, loss of appetite, bloating, inability to finish normal size meal and abdominal pain. There are not many drugs available to treat this condition and majority of gastroparetic patients are not responding well to them after they are on it for some time. Many investigators are able to implant Gastric Stimulator System (GES) under FDA approved status of Humanitarian Device Exemption (HDE) definition. In the last few years it became possible to add another surgical procedure, which is called pyloroplasty (making bigger opening on the end of stomach), may help even more as it is also increasing the rate of the emptying of the stomach. Therefore this study is proposing to evaluate if GES in combination with pyloroplasty is much better than pyloroplasty alone. For this reason, two of these procedures will be introduced surgically at the same time, but GES devices will not be turn ON in half of these participants for 3 months. After that time all subjects will have their devices turned ON. All subjects will be asked to evaluate their symptoms of gastroparesis and their quality of life during clinical visits, and investigators will conduct pathological analyses of tissue obtained during surgery.
Interventions
- DEVICE Gastric Electrical Stimulation (GES) System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2017-01-10 |
| Est. Completion | 2024-10-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03123809
The ClinicalTrials.gov registry entry for NCT03123809 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Texas Tech University Health Sciences Center, El Paso, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gastric Electrical Stimulation (GES) System is the first listed.
NCT03123809 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03123809 about?
NCT03123809 is a clinical study titled "Gastric Electrical Stimulation (GES) and Pyloroplasty for the Treatment of Gastroparesis". Gastroparesis (GP) is describing a condition when stomach does not empty as fast as it should. This fact creates the situation, when food stays in the stomach for a long time and it causes symptoms of nausea, vomiting, loss of appetite, bloating, inability to finish normal size meal and abdominal pa...
What is the current status of trial NCT03123809?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2017-01-10. Estimated completion is 2024-10-30.
What interventions are being tested in trial NCT03123809?
The interventions under investigation include: Gastric Electrical Stimulation (GES) System (DEVICE).
Who is sponsoring clinical trial NCT03123809?
This trial is sponsored by Texas Tech University Health Sciences Center, El Paso, which has 35 total clinical trials registered on ClinicalTrials.gov.
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