Acceptability and Tolerability of Magnetic Assisted Capsule Endoscopy Compared to Gastroscopy

NCT03420729 | Completed DMC

• 1 other identifier: STH19595
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dyspepsia

Outcome Measures

Primary Outcomes (1)

• Endoscopy Concerns Score

  Differences in the Endoscopy Concerns Score (ECS) when patients have magnetic assisted capsule endoscopy (MACE) and when they have conventional gastroscopy

  procedure

Secondary Outcomes (1)

• Clinician rating of visualization of upper GI Tract

  procedure

Study Arms (2)

magnetic assisted capsule endoscopy

EXPERIMENTAL

All participants will undergo magnetic assisted capsule endoscopy at the sloan medical centre

Procedure: gastroscopy; Device: magnetic assisted capsule endoscopy

gastroscopy

ACTIVE COMPARATOR

All participants will undergo gastroscopy as standard of care at sheffield teaching hospitals

Procedure: gastroscopy; Device: magnetic assisted capsule endoscopy

Interventions

gastroscopy PROCEDURE

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)

gastroscopy; magnetic assisted capsule endoscopy

magnetic assisted capsule endoscopy DEVICE

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.

gastroscopy; magnetic assisted capsule endoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

Gastroscopy; Endoscopy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Mark McAlindon

  Sheffield Teaching Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: March 7, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

GB (1)