Clinical Trials Directory

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

TypeNameDescription
DEVICEWireless Capsule Endoscopy
DEVICEMagnetically 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.