Can Steerable Capsule Endoscopy Enhance Gastric Emptying?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Observer Blinded Comparison of MACE and Conventional Upper Gastrointestinal Endoscopy in Upper GI Bleeding

NCT02690376

Gastrointestinal Diseases

COMPLETED NA

Robot-controlled Magnet-Assisted Capsule Endoscopy

NCT06030518

Abdominal Pain Upper Gastrointestinal Symptoms

UNKNOWN NA

Trial of Wireless Capsule Endoscopy in the Evaluation of Obscure Gastrointestinal Bleeding

NCT01006824

Obscure Gastrointestinal Bleeding (Occult or Overt)

COMPLETED PHASE4

Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding

NCT02219568

Gastrointestinal Bleeding

COMPLETED NA

Mini-sized MCE for Detection of Small Bowel in Children Under the Age of 10 Years

NCT05522101

Small Bowel Disease

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patients Attending Hospital for Small Bowel Endoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Wireless Capsule Endoscopy

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.

Group Type EXPERIMENTAL

Wireless Capsule Endoscopy

Intervention Type DEVICE

Magnetically steerable capsule endoscopy

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.

Group Type ACTIVE_COMPARATOR

Magnetically steerable capsule endoscopy

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Wireless Capsule Endoscopy

Intervention Type DEVICE

Magnetically steerable capsule endoscopy

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Swallowable pill camera

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No