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Trial registered on ANZCTR


Registration number
ACTRN12619000250134
Ethics application status
Approved
Date submitted
6/11/2018
Date registered
20/02/2019
Date last updated
12/02/2020
Date data sharing statement initially provided
20/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study into a Pan-Enteric Capsule Endoscopy vs. Bidirectional Endoscopy In Patients With Iron Deficiency Anaemia.
Scientific title
A Pilot Study into a Pan-Enteric Capsule Endoscopy vs. Bidirectional Endoscopy In Patients With Iron Deficiency Anaemia.
Secondary ID [1] 296527 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron Deficiency Anaemia 310308 0
Condition category
Condition code
Oral and Gastrointestinal 309042 309042 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Blood 309848 309848 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective pilot study into the performance of capsule endoscopy with bidirectional endoscopy (BDE) in patients with iron deficiency anaemia (IDA).
The rationale is to assess the quality and efficacy of the capsule endoscopy intervention in comparison to bidirectional endoscopy. Each endoscopic procedure will occur once for every patient, and both the endoscopy procedures will take place in the span of 48 hours. The capsule endoscopy procedure will be carried out after the patient arrives at the Peri-Operative Unit at 10am, and as soon as the pill is swallowed, the patient is allowed to leave the hospital and return home if no immediate side effects appear. The patient will be asked to return the following morning for the bidirectional endoscopy procedure. After the procedure, the patient will be in the recovery room for further observation and will be allowed to leave after eliminating all side effects of the procedure. All procedures will be carried out by trained gastroenterologists with experience in bidirectional and capsule endoscopy procedures. All procedures will be carried out under a clinical setting at the Royal Prince Alfred Hospital and Chris O'Brien Lifehouse in Sydney, Australia. Intervention will be provided face-to-face and individually to each patient enrolled in the trial.
Physical description of capsule used in capsule endoscopy is as follows:
Brand Name: PillCam
Version or Model: FGS-0662
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FGS-0662
Company Name: Covidien LP Primary DI Number: 07290110360559 Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use
Device Description: PillCam Crohn's capsule, 1-pack
Intervention code [1] 312837 0
Diagnosis / Prognosis
Comparator / control treatment
Bidirectional endoscopy is the comparator treatment for this study. Capsule endoscopy will be performed as a first procedure in patients with iron deficiency anaemia (IDA) followed by with bidirectional endoscopy (BDE) to assess accuracy and correlation of capsule endoscopy with pathology detection in patients receiving BDE for IDA.
Control group
Active

Outcomes
Primary outcome [1] 308003 0
To assess the sensitivity of capsule endoscopy for IDA in relation to bidirectional endosocpy
Timepoint [1] 308003 0
Primary outcomes of each patient will be measured after both procedures are complete and results have been interpreted by the interventional endoscopist performing the procedures.
Primary outcome [2] 319149 0
To assess the specificity of capsule endoscopy in relation to bidirectional endoscopy for IDA
Timepoint [2] 319149 0
Primary outcomes of each patient will be measured after both procedures are complete and results have been interpreted by the interventional endoscopist performing the procedures.
Secondary outcome [1] 353629 0
To assess the safety of capsule endoscopy and the types of missed lesions on capsule endoscopy
Timepoint [1] 353629 0
Secondary outcomes of each patient will be measured along with primary outcomes after results of both procedures are interpreted.

Eligibility
Key inclusion criteria
1. Adult patients with IDA according to the World Health Organisation criteria:
- Haemoglobin <13g/dL in men and <12g/dL in women
- Mean corpuscular volume (MCV) <80 OR ferritin <12-15 mg/L
2. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active bleeding (active GI loss, epistaxis, menorrhagia, heavy menstrual blood loss)
2. GI symptoms having IDA which included dysphagia, odynophagia, heartburn, vomiting, anorexia, hematochezia, change in bowel habits, unexplained diarrhea new onset constipation (within last 6 months), and localized abdominal pain
3. Prior GI tract surgery or NSAID use.
4. Known significant medical conditions (eg, congestive heart failure, renal disease), or other known contraindications to the medications used in the study
5. Cardiac pacemaker or other implanted electromedical devices.
6. Allergies or known contraindication to the medications and preparation agents used in the procedure as described in the relevant instructions for use
7. Pregnancy.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Summary statistics will be calculated for subject demographics and baseline characteristics of all subjects recruited for the study.
Safety will be assessed by characterizing each reported AE by type, severity, relationship to the study procedure or device, and outcome.
The diagnostic yield rate will be calculated for each modality, as will be their difference along with the corresponding 95% confidence interval (CI). The Wald confidence interval method for the difference of proportions with matched pairs will be used in calculating the yield difference for diagnostic yield rate for Capsule endoscopy and BDE. Additional analysis will be performed on per-subject and per-segment diagnostic yield outcomes to assess agreement between the Capsule endoscopy and BDE using kappa statistics. A two-tailed McNemar test will be used to compare the bowel cleansing level with Capsule endoscopy versus BDE.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/03/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12365 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 24626 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 301111 0
Commercial sector/Industry
Name [1] 301111 0
Medtronic Australasia Pty Ltd
Country [1] 301111 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
50 Missenden Road, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 300725 0
None
Name [1] 300725 0
Address [1] 300725 0
Country [1] 300725 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301861 0
Sydney Local Health District, Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 301861 0
Ethics committee country [1] 301861 0
Australia
Date submitted for ethics approval [1] 301861 0
17/09/2018
Approval date [1] 301861 0
12/11/2018
Ethics approval number [1] 301861 0
HREC/18/RPAH/541

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88354 0
A/Prof Arthur Kaffes
Address 88354 0
Suite G10, RPAH Medical Specialist Centre
100 Carillon Avenue
NEWTOWN NSW 2042
Provider No: 213052CB
Phone:
Fax:
Country 88354 0
Australia
Phone 88354 0
+61 2 9516 2033
Fax 88354 0
+61 2 9516 0778
Email 88354 0
arthur@kaffes.com
Contact person for public queries
Name 88355 0
Tatiana Tsoutsman
Address 88355 0
A.W. Morrow Gastroenterology and Liver Centre
Level 9 West, Building 75 Royal Prince Alfred Hospital Missenden Road Camperdown NSW 2050
Country 88355 0
Australia
Phone 88355 0
+61 2 9515 7383
Fax 88355 0
+61 2 9515 5182
Email 88355 0
Tatiana.Tsoutsman@health.nsw.gov.au
Contact person for scientific queries
Name 88356 0
Tatiana Tsoutsman
Address 88356 0
A.W. Morrow Gastroenterology and Liver Centre
Level 9 West, Building 75 Royal Prince Alfred Hospital Missenden Road Camperdown NSW 2050
Country 88356 0
Australia
Phone 88356 0
+61 29515 7383
Fax 88356 0
+61 2 9515 5182
Email 88356 0
Tatiana.Tsoutsman@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.