None listed
Conditions
Brief summary
Gastroesophageal reflux is an important cause of lung transplant rejection and so it is important to diagnose and treat in patients who hvae undergone or are to undergo transplantation. The Given ESO oesophageal capsule is a non-invasive disposable capsule endoscopy system which allows examination of the oesophagus. It has been trialled in many populations but not yet in the proposed study population.
Interventions
Patients will ingest the disposable Given ESO oesophageal video capsule to asses their oesophagus. After a brief 3 hour fast the patient swallows the video capsule (26x11mm) with a small amount of liquid. Images are captured via sticky electrodes attached to the chest. The procedure will take approximately 20 mins and the patient may return to usual activities immediately after. The images are downloaded onto a computer and a report is created. The patient is to observe their stools and if the c
Patients will ingest the disposable Given ESO oesophageal video capsule to asses their oesophagus. After a brief 3 hour fast the patient swallows the video capsule (26x11mm) with a small amount of liquid. Images are captured via sticky electrodes attached to the chest. The procedure will take approximately 20 mins and the patient may return to usual activities immediately after. The images are downloaded onto a computer and a report is created. The patient is to observe their stools and if the capsule is not sighted within 2 weeks an abdominal xray will be arranged to confirm passage. Although safe one of the risks is capsule retention in the bowels and if found the patient will be reviewed in clinic and likely have follow up xrays after a further period and if it remains insitu consideration to endoscopic or surgical removal. It is a single diagnostic procedure however if the images are poor a repeat examination may be undertaken.
Sponsors
GIVEN Imaging Australia (supply of video capsules)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients awaiting lung transplantation or recipients of lung transplantation.
Exclusion criteria
Have difficulty swallowing or have a known oesophageal diverticulum or stricture. Are pregnant or are planning pregnancy in next 6 weeks. Are under 18 years of age. Are unable to give valid informed consent. Have a cardiac pacemakers or defibrillator. Have suffered previous episodes of bowel obstruction: other than non-mechanical obstruction in patients with cystic fibrosis. Plan to have a MRI (magnetic resonance imaging) scan of any part of the body in the next 8 weeks.
Outcome results
None listed