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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: Completed NA study, sponsored by Texas Tech University Health Sciences Center, El Paso.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Severity and frequency of gastroparesis symptoms will be assess at baseline /surgery, after 3 months of randomized phase (GES ON or OFF), and at the end of 3 months of clinical follow up visit.
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 |
What the finished NCT03123809 record still lists
NCT03123809 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Gastric Electrical Stimulation (GES) System is the first listed.
NCT03123809 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03123809's enrollment target sits among peer trials
44 1423rd of 2000 higher than 566 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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