Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000271909
Ethics application status
Approved
Date submitted
14/03/2011
Date registered
15/03/2011
Date last updated
15/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Oesophageal capsule assessment of gastroesophageal reflux disease in chronic lung disease patients awaiting lung transplant and lung transplant recipients.
Scientific title
Oesophageal capsule assessment of gastroesophageal reflux disease in chronic lung disease patients awaiting lung transplant and lung transplant recipients.
Secondary ID [1] 259775 0
Nil
Universal Trial Number (UTN)
U1111-1119-9431
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastroesophageal reflux disease specifically in the chronic lung disease patients awaiting lung transplant and lung transplant recipient population 261359 0
Condition category
Condition code
Oral and Gastrointestinal 259518 259518 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Respiratory 259521 259521 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 264210 0
Diagnosis / Prognosis
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262320 0
Ability of ESO capsule to asses for GORD in the study population. This will be assesed by interpretation within clinical consultation, standardised reflux questionaire and further clinical investigations eg endoscopy, as clinically indicated as per current best practice.
Timepoint [1] 262320 0
After review of the images of the capsule study and clinical information this will be assesed.
Secondary outcome [1] 273537 0
Tolerability of the ESO capsule in the study population. This will be assesed by a post ingestion questionaire and whether the capsule passes by the 2 week mark without complication.
Timepoint [1] 273537 0
2 weeks after ingestion.

Eligibility
Key inclusion criteria
Patients awaiting lung transplantation or recipients of lung transplantation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be recruited from the Queensland Centre for Thoracic Transplantation outpatients and offered to enter study. All patients entered will have ESO capsule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264654 0
Self funded/Unfunded
Name [1] 264654 0
Country [1] 264654 0
Primary sponsor type
Commercial sector/Industry
Name
GIVEN Imaging Australia (supply of video capsules)
Address
Given Imaging Pty Ltd
Unit 6A, The Park
5 Talavera Road
North Ryde NSW 2113
Australia
Country
Australia
Secondary sponsor category [1] 263796 0
None
Name [1] 263796 0
Address [1] 263796 0
Country [1] 263796 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266650 0
The Prince Charles Hospital HREC
Ethics committee address [1] 266650 0
The Prince Charles Hospital
Rode Rd
CHERMSIDE
QUEENSLAND
4032
Ethics committee country [1] 266650 0
Australia
Date submitted for ethics approval [1] 266650 0
Approval date [1] 266650 0
16/12/2010
Ethics approval number [1] 266650 0
HREC/10/QPCH/183

Summary
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.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32339 0
Address 32339 0
Country 32339 0
Phone 32339 0
Fax 32339 0
Email 32339 0
Contact person for public queries
Name 15586 0
Dr Nicholas Tutticci
Address 15586 0
Endoscopy Unit
The Prince Charles Hospital
Rode Rd
CHERMSIDE
QLD
4032
Country 15586 0
Australia
Phone 15586 0
+617 31396801
Fax 15586 0
Email 15586 0
[email protected]
Contact person for scientific queries
Name 6514 0
Dr Nicholas Tutticci
Address 6514 0
Endoscopy Unit
The Prince Charles Hospital
Rode Rd
CHERMSIDE
QLD
4032
Country 6514 0
Australia
Phone 6514 0
+617 31396801
Fax 6514 0
Email 6514 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.