Acceptability and Tolerability of Magnetic Assisted Capsule Endoscopy Compared to Gastroscopy

April 23, 2024 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

Dyspepsia is a common presenting complaint that doctors have to manage and this is true both in the primary and secondary care setting. OGD is a useful test for investigating a variety of suspected upper GI disorders including dyspepsia. However, it is uncomfortable for patients and incurs the risk of intubation and sedation. Capsule endoscopy (CE) is the investigation of choice for diseases of the small bowel. It is safe, non-invasive and well tolerated, the main risk being capsule retention occurring in up to 1-2% of procedures.

The investigators wish to undertake a prospective study comparing acceptability and tolerability of MACE and OGD in the investigation of dyspepsia. Patients presenting to general practice or the outpatients department with symptoms of dyspepsia who are referred for investigation are invited to take part in the study. Patients will undergo MACE prior to OGD performed by an endoscopist blinded to the MACE findings. . A comparison of tolerance and acceptance of both procedures will be measured by means of using structured and validated, qualitative questionnaires. The aim is to assess for whether there is a significant difference between the perception and experience of both modalities.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, single blinded, comparative trial of patient acceptability and tolerability of MACE and both transoral and transnasal gastroscopy in the investigation of dyspepsia.

The study will be conducted within Sheffield Teaching Hospitals. Recruitment will take place at the Sloan Medical Centre, the Royal Hallamshire Hospital or the Northern General Hospital during the consultation when patients present with dyspepsia requiring gastroscopy for investigation as per national guidelines. MACE will take place at the Sloan Medical Centre. Equipment for collecting demographics (height, weight etc) will be available. All the capsule equipment is stored and re-charged in this designated room. The case report files and computer data will be stored in this room that is secured by a locked door.

Gastroscopy will take place in the Endoscopy Departments, which are specially designed units for a variety of endoscopic tests, at the Royal Hallamshire Hospital and Northern General Hospital.

Patients are assessed in the Sloan Medical Centre or the Royal Hallamshire Hospital/Northern General Hospital outpatients department for their primary presenting complaints of dyspepsia. The study will be discussed with patients in those who satisfy the enrolment criteria and they will be provided by with the written study literature. If in agreement to enter the study, informed written consent will be obtained from the patient.

Prior to any investigation, the pre-MACE section of the questionnaire will be completed by the patient with the assistance of study team members. MACE will be performed at the Sloan Medical Centre; this will be in a dedicated room setup to accommodate the MACE procedure.The post-MACE section of the questionnaire will then be completed by the patient with the assistance of study team members. MACE will be preceded by obtaining measurements of height, weight and waist/hip circumference. The patient will then be given 500 to 1000mls of water with 6 drops of simethicone added to drink. This is to enable adequate distension of the stomach. Our previous study has shown excellent tolerance of this volume of water distension by patient.

The patient then swallows the capsule in the presence of the PI. MACE of the oesophagus and stomach will be carried out by the PI. Once the PI is satisfied that an adequate examination has been completed the capsule will be allowed to pass into and through the small bowel. Visibility of major locations of the stomach will be documented. Any pathology noted will be recorded according to the standard fashion described for gastroscopy reporting. A note of the procedure duration will be recorded. The patient will be given the option to complete their small bowel capsule endoscopy in the standard way and this will be reported in the usual fashion.

Patients referred for gastroscopy as part of the normal pathway for investigation of dyspepsia, will attend a designated list for their gastroscopy within 1 week and this will be performed by a JAG accredited endoscopist who has experience in endoscopic therapy. TOG will be performed using a standard 11mm Olympus or Pentax gastroscope and TNG will be performed using an ultra-thin 5.9mm Olympus or Fujinon gastroscope. The endoscopist performing the gastroscopy will be a member of the study team. The participant will be asked to complete the pre-gastroscopy section of the participant questionnaire before, and the post-gastroscopy section after the procedure.

Patients will have 80mg simethicone mixed in 100mls of water as an anti-foaming agent prior to the gastroscopy. Patients undergoing TNG will have their nasal passages prepared with a fine mist of 5% lidocaine and 0.5% phenylephrine (co-phenylephrine nasal spray) which are a local anaesthetic and nasal decongestant. Phenylephrine is a topical vasoconstrictor used as a nasal decongestant to reduce the risk of peri-procedure epistaxis. Five minutes following this, a 6mm diameter soft-sillicone catheter lubricated with 2% aqueous lidocaine gel is inserted into either or each nasal passage approximately 5-8cm passages to ensure the passage is wide enough to comfortably accommodate a nasal endoscopy. If neither passages accommodate the silicone catheter, the procedure will be converted to a transoral route. Patients undergoing TOG will have 10 sprays of 10% topical lidocaine administered to the oropharynx. Procedures will be performed in the left lateral decubitus position.

Gastroscopy will be performed in the standard fashion and reported to the PI to compose a written record for study purposes. This reporting system (InfoFlex) requires details to be entered regarding indication for examination, patient comfort, sedation and pathology. Pathology will be documented in a standardised way (for further details see section on Scientific Justification). An entry of the duration of procedure will be included. This denotes the end of the participants' involvement in the study. The patient will be managed thereafter according to the responsible clinician at the Sloan Medical Centre or Sheffield Teaching Hospitals NHS Trust.

The primary outcome will be evaluated using the questionnaires to compare acceptability and tolerance of both procedures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18 years and over and up to but not exceeding 80 years
  • Patients presenting symptoms of dyspepsia whom require gastroscopy as per national guidelines

Exclusion Criteria:

Patients under the age of 18 years

  • Patients over the age of 80 years
  • Active vomiting
  • Patients with a permanent pacemaker, implantable cardioverter-defibrillator or REVEAL device
  • Patients with any electronic/magnetic/mechanically controlled devices e.g. sacral nerve stimulators, bladder stimulators
  • Patients with dysphagia, odynophagia or known swallowing disorder
  • Patients with known Zenker's diverticulum
  • Patients with suspected bowel obstruction or bowel perforation
  • Patients with prior bowel obstruction
  • Patients with gastroparesis or known gastric outlet obstruction
  • Patients with known Crohn's disease
  • Patients who are taking daily non-steroidal anti-inflammatory drugs (excluding prophylactic doses of aspirin) for more than six months
  • Patients who have received abdominopelvic radiotherapy treatment
  • Patients with a history of GI tract surgery (Billroth I, Billroth II, Oesophagectomy, gastrectomy or bariatric procedure)
  • Patients that are pregnant or lactating
  • Patients with altered mental status that would limit their ability to swallow
  • Patients with allergy to conscious sedation or metoclopramide
  • Patients unwilling to swallow the capsule
  • Patients with known dementia affecting ability to consent
  • Patients who are unable to understand or speak English
  • Patients unable to provide written informed consent
  • Patients with head and neck cancers
  • Patients who have had nasal surgery, eg. rhinnoplasty
  • Patients allergic to lidocaine, pheylephirine or midazolam
  • Patient with bleeding diathesis, on warfarin or have chronic liver disease
  • Patients reluctant to have gastroscopy by both oral or transnasal route

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: magnetic assisted capsule endoscopy
All participants will undergo magnetic assisted capsule endoscopy at the sloan medical centre
Procedure: gastroscopy
a thin, flexible tube called an end oscope is used to look inside the oesophagus (gullet), stomach and first part of the small intestine (duodenum)
Device: magnetic assisted capsule endoscopy
The patient will be given 500 to 1000mls of water with 6 drops of simethicone added to drink. This is to enable adequate distension of the stomach. The patient then swallows the capsule in the presence of the PI. MACE of the oesophagus and stomach will be carried out by the PI. Once the PI is satisfied that an adequate examination has been completed the capsule will be allowed to pass into and through the small bowel.
Active Comparator: gastroscopy
All participants will undergo gastroscopy as standard of care at sheffield teaching hospitals
Procedure: gastroscopy
a thin, flexible tube called an end oscope is used to look inside the oesophagus (gullet), stomach and first part of the small intestine (duodenum)
Device: magnetic assisted capsule endoscopy
The patient will be given 500 to 1000mls of water with 6 drops of simethicone added to drink. This is to enable adequate distension of the stomach. The patient then swallows the capsule in the presence of the PI. MACE of the oesophagus and stomach will be carried out by the PI. Once the PI is satisfied that an adequate examination has been completed the capsule will be allowed to pass into and through the small bowel.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Endoscopy Concerns Score
Time Frame: procedure
Differences in the Endoscopy Concerns Score (ECS) when patients have magnetic assisted capsule endoscopy (MACE) and when they have conventional gastroscopy
procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinician rating of visualization of upper GI Tract
Time Frame: procedure
Differences in visualization of the upper GI tract
procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark McAlindon, Sheffield Teaching Hospitals NHS FT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STH19595

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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