Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000670673
Ethics application status
Approved
Date submitted
11/10/2005
Date registered
20/10/2005
Date last updated
20/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Performance Evaluation of the GIVEN Patency System
Scientific title
Performance Evaluation of the GIVEN Patency System in Patients with known small bowel strictures
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with known small bowel strictures 818 0
Condition category
Condition code
Oral and Gastrointestinal 882 882 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This multi center study will assess the ability of the GIVEN Patency System to verify the patency of the GI tract in patients with known strictures in the small bowel. The overall plan for all patients consists of the following elements:
Patient is assessed for his eligibility to participate in the study.
Patient ingests a GIVEN Patency Capsule.
Patient is followed using the GIVEN Patency Scanner until the excretion of the capsule and/or its components.
Patients will undergo fluoroscopy 32-38 hours after ingestion.
Patients will undergo fluoroscopy (as applicable) 68-72 hours after ingestion
Patients will undergo fluoroscopy (as applicable) 94-100 hours after ingestion
Patient with patent GI tract will undergo PillCam SB Capsule Endoscopy to further assess the patient's condition and evaluate the correlation between the results of GIVEN Patency Capsule passage and the PillCam SB Capsule findings
Intervention code [1] 713 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 1139 0
To evaluate the performance of the GIVEN Patency System by demonstrating its ability to verify the patency of the gastro-intestinal (GI) tract in patients in whom strictures have been identified by conventional modalities such as small-bowel-follow-through (SBFT), CT-scan, etc
Timepoint [1] 1139 0
Primary outcome [2] 1140 0
The transit time of capsules and/or tags from ingestion to excretion.
Timepoint [2] 1140 0
Primary outcome [3] 1141 0
For cases where the GIVEN Patency System finds the GI patent: smooth passage of PillCam SB video Capsule without delay or retention
Timepoint [3] 1141 0
Secondary outcome [1] 2103 0
Number and severity of adverse events directly related to the use of the GIVEN Patency System.
Timepoint [1] 2103 0
Secondary outcome [2] 2104 0
The location and conditions of the capsule as assessed by fluoroscopy procedure.
Timepoint [2] 2104 0
Secondary outcome [3] 2105 0
The condition of the capsule following excretion.
Timepoint [3] 2105 0

Eligibility
Key inclusion criteria
1. Patient is known to suffer from intestinal stricture based on an X-ray test, and/or SBFT and/or abdominal CT scan performed within the last 3 months [these tests will be repeated only if there are recent changes in the patients clinical conditions during this period. 2. Patient is able and agrees to sign the Informed Consent Form.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient suffers from swallowing disorders 2. Patient has less than 2 bowel movements per week (to be confirmed by bowel movement log)3. Female patient is pregnant (women of childbearing potential will have to perform a urine pregnancy test before the ingestion).4. Patient has any condition, which precludes compliance with study and/or device instructions.5.Patient has cardiac pacemakers or other electro medical implant6.Patient suffers from life threatening conditions7.Patient is currently participating in another clinical study.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
11/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 972 0
Commercial sector/Industry
Name [1] 972 0
Given Imaging Ltd.
Country [1] 972 0
Israel
Primary sponsor type
Commercial sector/Industry
Name
Given Imaging Ltd., New Industrial Park, Yoqneam, Israel
Address
Country
Israel
Secondary sponsor category [1] 840 0
None
Name [1] 840 0
Nil
Address [1] 840 0
Country [1] 840 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36272 0
Address 36272 0
Country 36272 0
Phone 36272 0
Fax 36272 0
Email 36272 0
Contact person for public queries
Name 9902 0
Melissa Cohen
Address 9902 0
Given Imaging Pty Ltd
Unit 4
Rydelink Business Park
277 Lane Cove Road
North Ryde NSW 2113
Country 9902 0
Australia
Phone 9902 0
+61 2 98893944
Fax 9902 0
+61 2 98893955
Email 9902 0
[email protected]
Contact person for scientific queries
Name 830 0
Melissa Cohen
Address 830 0
Given Imaging Pty Ltd
Unit 4
Rydelink Business Park
277 Lane Cove Road
North Ryde NSW 2113
Country 830 0
Australia
Phone 830 0
+61 2 98893944
Fax 830 0
+61 2 98893955
Email 830 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.