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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00766935




Registration number
NCT00766935
Ethics application status
Date submitted
2/10/2008
Date registered
6/10/2008
Date last updated
27/08/2021

Titles & IDs
Public title
The Equivalency of the Imp SFB7+ (L-Dex U400) With the Imp XCA Device
Scientific title
The Equivalency of the Imp SFB7+ (L-Dex U400) With the Imp XCA Device
Secondary ID [1] 0 0
UQSFB7+-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphedema 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1 - lymphoedema group - Females with previously diagnosed unilateral Lymphoedema of the arm, who have had a mastectomy or breast conservation surgery with axillary sampling or dissection, with or without adjuvant therapy.

2 - healthy individuals - Healthy females aged between 18-75 years chosen randomly from the population of Queensland, Australia.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Substantial equivalence of the SFB7+ (L-Dex U400) to XCA in the assessment Lymphoedema
Timepoint [1] 0 0
Single point measure

Eligibility
Key inclusion criteria
Groups 1 and 2

* Be female between the ages of 18-75 years.
* Self-describe general health as satisfactory.
* Understand the proposed study and be willing and fully able to comply with the study procedures.
* Be a willing participant and be capable of giving and has given informed written consent for entry into the study.

Group 1

* Have been previously diagnosed, by current clinical practice, as having unilateral Lymphoedema of the arm of any severity.
* Have had a mastectomy or breast conservation surgery with axillary sampling or dissection, with or without adjuvant therapy.
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Have a known heart condition or an implantable device such as a pacemaker or ICD.
* Have a metallic surgical implant (e.g. total hip replacement) not including small implants such as sternal wires or surgical staples.
* Suffer from a renal disorder.
* Be taking diuretic medications.
* Have consumed large amounts of alcohol or caffeinated beverages within six hours of the study.
* Have undertaken excessive exercise within two hours of BIA.
* Have a reported fever of > 38oC at time of screening.
* Be currently in the fourth week of the menstrual cycle.
* Be pregnant or currently breastfeeding.
* Be a relative of any member of study staff or is an employee or a relative of an employee of ImpediMed Ltd.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2008
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Queensland Lymphoedema and Breast Oncology Physiotherapy - Brisbane
Recruitment postcode(s) [1] 0 0
4032 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ImpediMed Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this project is to prove that the Imp™SFB7+ (L-Dex U400) is equivalent to the Imp™ XCA device in assessing Lymphoedema. The Imp™ XCA device is a simple device capable of assessing Lymphoedema of a single arm. The Imp™SFB7+ (L-Dex U400) is a more complex device capable of assessing Lymphoedema in a larger population of Lymphoedema sufferers. The Imp™SFB7+ (L-Dex U400) will be developed to assess patients with Lymphoedema in their arms or their legs. The Imp™ XCA and Imp™ SFB7 are both TGA approved devices. The Imp™ SFB7+ (L-Dex U400) is similar to the Imp™ SFB7 the changes are to the software and user interface.
Trial website
https://clinicaltrials.gov/study/NCT00766935
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robyn Box, PhD
Address 0 0
Queensland Lymphoedema and Breast Oncology Physiotherapy
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00766935