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NCT01916460 · ClinicalTrials.gov registry record · NA
Intraluminal Endosonography for Examination of the Structural Changes of the Stomach in Gastroparetic Patients
A NA study, sponsored by Texas Tech University Health Sciences Center, El Paso.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT01916460 is a NA study that has completed, run by Texas Tech University Health Sciences Center, El Paso. The registered enrollment target is 11 participants.
The verdict
NCT01916460, a NA study, has completed, sponsored by Texas Tech University Health Sciences Center, El Paso.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
Patients who empty their stomach slowly may have what we call "Slow gastric emptying" or "gastroparesis". These patients can have some changes in the thickness of their stomach wall. In addition, they may have loss of some important nerve cells in their stomach muscles. The loss of these cells can cause slow emptying of the stomach. Obtaining a sample from the stomach wall to examine the loss of these cells can help in diagnosing gastroparesis. Up to now, the only way to obtain a tissue sample from the stomach muscle was to undergo an operation in the surgery suite and be hospitalized for several days after the procedure. Usually, we obtain this sample while these patients are having a surgery for another purpose such as placement of a gastric stimulator (a machine which is inserted in the stomach wall to control the stomach rhythm and thus help the stomach to empty faster). Endoscopic ultrasound is an endoscope (a tube with a source of light and ultrasound installed in the tip of the tube) that can measure how thick the stomach wall is and can provide sample "biopsies" of the stomach wall which can be studied for the loss of these specialized muscles and cells. We are proposing that samples obtained by the endoscopic ultrasound can be sufficient to diagnose "gastroparesis" and can replace the need for obtaining samples by surgery. Endoscopic ultrasound is an outpatient procedure which is not as invasive as surgery.
Interventions
- PROCEDURE Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01916460
The ClinicalTrials.gov registry entry for NCT01916460 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 11 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 Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) is the first listed.
NCT01916460 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01916460 about?
NCT01916460 is a clinical study titled "Intraluminal Endosonography for Examination of the Structural Changes of the Stomach in Gastroparetic Patients". Patients who empty their stomach slowly may have what we call "Slow gastric emptying" or "gastroparesis". These patients can have some changes in the thickness of their stomach wall. In addition, they may have loss of some important nerve cells in their stomach muscles. The loss of these cells can c...
What is the current status of trial NCT01916460?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2013-03. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01916460?
The interventions under investigation include: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) (PROCEDURE).
Who is sponsoring clinical trial NCT01916460?
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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