Trials / Completed
CompletedNCT02282852
Can Steerable Capsule Endoscopy Enhance Gastric Emptying?
Randomised Comparison of a Standard Protocol Using Metoclopramide Versus a Hand Held Magnet to Enhance Gastric Emptying of the Small Bowel Capsule.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
Small bowel wireless capsule endoscopy is the investigation modality of choice for suspected diseases of the small bowel. The procedure is safe and noninvasive, the main risk being capsule retention occurring in approximately 2% of procedures. Other problems such as incomplete examinations occur in 10-20% of procedures. Reasons include delayed gastric emptying, slow small bowel transit, faulty equipment and poor bowel preparation. Some protocols identify the capsule position 30 minutes after ingestion using a 'realtime' viewer. If the capsule remains in the stomach, mobilisation is encouraged followed by an intramuscular prokinetic injection if this fails. This approach has disadvantages since an intramuscular injection is uncomfortable for patients. Additionally metoclopramide, commonly used for this purpose, has a risk of acute dystonic reactions particularly in young patients. Recently a handheld magnet (Intromedic Ltd.) has been developed to enable control of the capsule in the upper GI tract. We propose that this could be used, alongside positional changes, to expedite capsule transit through the stomach thus improving completion rates and avoiding the risks of unnecessary medication. We wish to undertake a randomised controlled study comparing a standard protocol for small bowel capsule endoscopy against a hand held magnet and positional change protocol to enhance gastric emptying of the wireless capsule.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Wireless Capsule Endoscopy | |
| DEVICE | Magnetically steerable capsule endoscopy |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2015-03-01
- Completion
- 2015-03-01
- First posted
- 2014-11-04
- Last updated
- 2015-03-23
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02282852. Inclusion in this directory is not an endorsement.