NCT02282852

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 23, 2015

Status Verified

October 1, 2014

Enrollment Period

1.2 years

First QC Date

October 31, 2014

Last Update Submit

March 20, 2015

Conditions

Patients Attending Hospital for Small Bowel Endoscopy

Outcome Measures

Primary Outcomes (2)

  • Completion rate of small bowel endoscopy examination

    Baseline

  • Duration of time taken for camera capsule to enter duodenum.

    Baseline

Study Arms (2)

Wireless Capsule Endoscopy

EXPERIMENTAL

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.

Device: Wireless Capsule Endoscopy

Magnetically steerable capsule endoscopy

ACTIVE COMPARATOR

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.

Device: Magnetically steerable capsule endoscopy

Interventions

Wireless Capsule EndoscopyDEVICE
Also known as: Swallowable pill camera
Wireless Capsule Endoscopy
Magnetically steerable capsule endoscopyDEVICE
Magnetically steerable capsule endoscopy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Interventions

Capsule EndoscopyEndoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Mark McAlindon, MD

    Sheffield Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 4, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 23, 2015

Record last verified: 2014-10

Locations

GB(1)