Non-invasive Measurement of Gastric Motility

Greg O'Grady

Status: Unknown

Conditions: Adults,Gastric Symptoms,Suspected Gastric Motility Disorders

Treatments: Device: Gastric Alimetry

Study type: Observational

Funder types: Other

Identifiers

NCT04992884

CLD-014

Details and patient eligibility

About

Clinical evaluation to compare performance of the physiological recordings from the Gastric Alimetry System vs a predicate reference device (Medtronic Polygram NET / Polygraf ID EGG System

Full description

A prospective, non-randomised, single centre investigation on patients with suspected motility disorders comprising a simultaneous head-to-head comparison of device performance between the Gastric Alimetry System and the Medtronic Polygram NET / Polygraf ID EGG System.

Enrollment: 25 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 22 years old or older
• Able to provide written informed consent
• Patients with a suspected motility disorder, meetingRome IVCriteria for functional dyspepsia or chronic nausea and vomiting syndromes or having a diagnosis of gastroparesis as confirmed by a standardized gastric scintigraphy study, including having >10% gastric meal retention at 4-hours.

Exclusion criteria

• BMI >35 kg m(2)
• Known metabolic, neurogenic or endocrine disorders known to cause gastrointestinal dysmotility e.g. multiple sclerosis, Parkinson's disease, hypothyroidism
• Known current gastrointestinal infection (includes H.pylori when being actively treated)
• Known current inflammatory bowel disease
• Known current gastrointestinal malignancy
• Previous gastroduodenal surgery
• Open abdominal wounds or abdominal skin not intact (e.g.rash, abrasions, weeping tissues)
• Fragile skin evidenced by high susceptibility to skin tears or skin that bruises easily
• Regular cannabis use
• Allergy to adhesives
• Pregnancy