Status:
COMPLETED
Acceptability and Tolerability of Magnetic Assisted Capsule Endoscopy Compared to Gastroscopy
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Conditions:
Dyspepsia
Eligibility:
All Genders
18-80 years
Phase:
NA
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 up...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT03420729
Start Date
March 7 2017
End Date
September 1 2020
Last Update
April 25 2024
Active Locations (1)
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1
Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2JF