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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: Completed NA study, sponsored by Texas Tech University Health Sciences Center, El Paso.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Wither FNA needle can obtain sufficient muscularis propria tissue from the gastric wall to perform histological staining for the interstitial cell of Cajal and smooth muscles markers. The specimen from the FNA needle will be compared to the standard full thickness gastric biopsy which is routinely obtained in our institution during the surgical placement of the gastric stimulator.
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 |
What the finished NCT01916460 record still lists
NCT01916460 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) is the first listed.
NCT01916460 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01916460's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 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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