Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT04840433
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04840433
Study Brief:
Protocol Section:
NCT04840433