Iron Deficiency Anemia Clinical Trial
— A-MACEOfficial title:
Location of Lesions Responsible for Blood Loss in the Gastrointestinal (GI) Tract
The purpose of this study is to identify the prevalence, nature and location of lesions in the GI tract that may contribute to iron deficiency anaemia and compare diagnostic yied of the upper GI magnetic controlled capsule endoscopy with conventional gastroscopy.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | December 31, 2022 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Male and female patients aged 18 years and over and up to but not exceeding 80 years - Patients presenting with IDA whom require gastroscopy and colonoscopy as per national guidelines (1) Exclusion Criteria: - Patients who have contraindications to gastroscopy or colonoscopy - 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, polyethylene glycol 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Shatin | New Territories |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence and nature of lesions in the upper GI tract, small bowel and colon that cause IDA | Prevalence and nature of lesions in the upper GI tract, small bowel and colon that cause IDA | 1.5 years | |
Secondary | Comparison of diagnostic performance between MACE and gastroscopy in the upper GI tract in detecting lesions that cause IDA | Comparison of diagnostic performance between MACE and gastroscopy in the upper GI tract in detecting lesions that cause IDA | 1.5 years | |
Secondary | Comparison of patient acceptability of MACE and gastroscopy by patient questionnaire | Comparison of patient acceptability of MACE and gastroscopy by patient questionnaire | 1.5 years |
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