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:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT05719168
Eligibility Criteria:
Healthy controls
Inclusion Criteria:
* Aged 18-70 years old
* BMI 18-35
* Able to understand written and spoken English
* Able to provide written consent
* Able to understand risks and benefits
Exclusion Criteria:
* Antacid use (e.g. PPI, H2RA or Gaviscon) within last 12-months
* Active use of other medications known to impact gastric motility
* Upper GI symptoms including but not limited to heartburn, regurgitation, epigastric pain, nausea and bloating
* Significant medical condition
* History of skin allergies or hypersensitivity
* Active abdominal wounds or abrasions, fragile skin
* Current pregnancy
* Vulnerable group e.g. prisoners/cognitive impairment/institutionalised individuals
* Regular cannabis users (unable to abstain for 7-days)
* Opioid user
* Unable to use a tablet device
GORD patients
Inclusion Criteria
* Referred for 24-hour pH-impedance monitoring
* Aged 18-70 years old
* BMI 18-35
* Able to understand written and spoken English
* Able to provide written consent
* Able to understand risks and benefits
Exclusion Criteria
* Systemic or metabolic disorder known to cause gastric dysmotility other than diabetes (e.g. scleroderma, multiple sclerosis, hyperthyroidism).
* History of upper GI surgery or hiatal hernia (\>5cm, paraesophageal, or 'large' on endoscopy report)
* Diabetic and on insulin
* Proven mechanical bowel obstruction
* History of skin allergies or hypersensitivity
* Active abdominal wounds or abrasions, fragile skin
* Current pregnancy
* Vulnerable group - prisoners/cognitive impairment/institutionalised individuals
* Regular cannabis users (unable to abstain for 7-days)
* Opioid user
* Unable to use a tablet device
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05719168
Study Brief:
Protocol Section:
NCT05719168