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NCT00702533 · ClinicalTrials.gov registry record
A New Method for Determining Gastric Acid Output Using a Wireless Capsule
A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 80
- Enrollment target
NCT00702533: Completed study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00702533 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 80 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00702533 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 80 participants
- Enrollment target
Study Summary
Background: \- Acid-related gastrointestinal disorders are numerous and may require chronic treatment and maintenance, but they are often difficult to diagnose and treat. Gastric analysis is a critical tool for diagnosing and treating acid-related disorders; however, at present it requires a technically difficult procedure, using a nasogastric tube, that is costly, invasive, and uncomfortable. Recently a new tool, the SmartPill, has been developed that can measure acid levels, temperature, and pressure throughout the stomach, small intestine, and colon by swallowing a small capsule. Researchers are interested in comparing current methods of measuring stomach acid with the SmartPill by studying both healthy volunteers and individuals with acid-related gastrointestinal disorders. Objectives: \- To evaluate the usefulness and accuracy of the SmartPill for gastric analysis, compared with current procedures. Eligibility: * Phase 1A/1B: Healthy volunteers between 18 and 60 years of age. * Phase 2: Individuals at least 18 years of age who have been diagnosed with Zollinger-Ellison Syndrome or acid hypersecretion. * Phase 3: Individuals at least 18 years of age who have been diagnosed with refractory gastroesophageal reflux disease, peptic ulcer disease, or idiopathic gastric hypersecretion. Design: * This study involves a screening visit, a 3-day inpatient study visit, and possible additional outpatient visits. * Participants will be screened with a medical history and physical examination, as well as blood and urine samples. * Phase 1A/1B: Participants will have a 3-day inpatient study visit with the following procedures: * Imaging study of the stomach (simultaneous gastric emptying scintigraphy), followed by a special diet for the next day s test. * Gastric analysis using a nasogastric tube to collect stomach acid secretions. * SmartPill study, in which participants will ingest a SmartPill and wear a monitor for 24 to 48 hours to collect readings. * Participants i
Primary Outcome
This study examines the safety and efficacy of disposable, wireless capsule (SmartPill) devices in determining gastric acid output in comparison to current standard gastric aspiration procedures, which are more invasive and inconvenient.
Interventions
- DEVICE Pentagastrin Injection BP
- DRUG Pentagastrin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2008-06-18 |
What the finished NCT00702533 record still lists
NCT00702533 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Pentagastrin Injection BP is the first listed.
NCT00702533 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00702533 about?
NCT00702533 is a clinical study titled "A New Method for Determining Gastric Acid Output Using a Wireless Capsule". Background: \- Acid-related gastrointestinal disorders are numerous and may require chronic treatment and maintenance, but they are often difficult to diagnose and treat. Gastric analysis is a critical tool for diagnosing and treating acid-related disorders; however, at present it requires a techni...
What is the current status of trial NCT00702533?
This trial is currently completed. The enrollment target is 80 participants. The study started on 2008-06-18.
What interventions are being tested in trial NCT00702533?
The interventions under investigation include: Pentagastrin Injection BP (DEVICE), Pentagastrin (DRUG).
Who is sponsoring clinical trial NCT00702533?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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