Can Steerable Capsule Endoscopy Enhance Gastric Emptying?

NHS Foundation Trust logo

NHS Foundation Trust

Status

Completed

Conditions

Patients Attending Hospital for Small Bowel Endoscopy

Treatments

Device: Magnetically steerable capsule endoscopy
Device: Wireless Capsule Endoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT02282852
STH17268

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients aged 20 years or over
  • Patients attending hospital for small bowel endoscopy examination

Exclusion criteria

  • Patients under the age of 20 years
  • Patients with a permanent pacemaker, or implantable cardioverter-defibrillator
  • Patients with any electronic/magnetic/mechanically controlled devices
  • Patients that are pregnant
  • Patients who are unable to understand or speak English

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

24 participants in 2 patient groups

Wireless Capsule Endoscopy
Experimental group
Description:
Wireless capsule endoscopy is the investigation modality of choice for suspected diseases of the small bowel. A small pill-sized capsule contianing a camera is swallowed by the patient. The procedure is safe and non-invasive. Normally, the pill camera travels through the gut an exits the bowel via natural means. In a small number of cases the capsule is maintained. If the capsule is still in the stomach, mobilisation is encouraged followed by an intramuscular pro-kinetic injection if this fails.
Treatment:
Device: Wireless Capsule Endoscopy
Magnetically steerable capsule endoscopy
Active Comparator group
Description:
A handheld magnet (manufactured by Intromedic Ltd.) has been developed to allow some control of the pill camera (that contains a small amount of magnetic material) 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.
Treatment:
Device: Magnetically steerable capsule endoscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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