LymphedemaNCT00766935
The Equivalency of the Imp SFB7+ (L-Dex U400) With the Imp XCA Device
An observational study of Lymphedema, run by ImpediMed Limited at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lymphedema
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2007to Apr 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1 - Primary care clinic Group 2 - Community sample
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Queensland Lymphoedema and Breast Oncology Physiotherapy
Brisbane, Queensland, 4032
About this study
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.
Read the detailed description
When Lymphoedema is present, lymph and other fluids build up in the interstitial spaces of the tissues. This results in an overall increase in the total amount of extracellular fluid (ECF) in the limb, causing swelling. This can be documented by measuring the impedance (opposition) to a low frequency current that has been passed into the limb. Low frequency current travels predominantly through the ECF, where the Lymphoedema manifests. As the fluid builds up in the limb, the impedance to the current decreases and it is in this way that low frequency bioimpedance is able to assess Lymphoedema.
Multi-frequency bio-impedance analysis otherwise known as Bioimpedance Spectroscopy (BIS) has been reported to be effective for the measurement of ECF and sub clinical changes in ECF to predict the onset of Lymphoedema in the arms in studies conducted by Cornish et al. It has been reported by Warren et al that BIS can be used as a reliable and accurate tool for documenting presence of lymphoedema in patients with wither upper- or lower-extremity swelling.
The Imp™ XCA device uses an "impedance ratio" methodology to assess unilateral Lymphoedema of the arm. By this method the unaffected arm acts as an internal and subject specific control. The Imp SFB7+ (L-Dex U400) uses the same principles but at a lower frequency. This study is designed to show the equivalence of the 2 devices in assessing unilateral Lymphoedema of the arm.
- Conditions
- Lymphedema
- Keywords
- Lymphedema, Bioimpedance
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substantial equivalence of the SFB7+ (L-Dex U400) to XCA in the assessment Lymphoedema
Observation of difference between L-Dex values of lymphoedema population compared to healthy individuals
Measured: Single point measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImpediMed Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robyn Box, PhD, Principal investigator, Queensland Lymphoedema and Breast Oncology Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766935
- Sponsor's protocol ID
- UQSFB7+-01
- Status last verified
- Aug 2021
- First submitted
- 2 Oct 2008
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Equivalency of the Imp SFB7+ (L-Dex U400) With the Imp XCA Device
- ClinicalTrials.gov ID
- NCT00766935
- Acronym / sponsor ID
- UQSFB7+-01
- Conditions
- Lymphedema
- Keywords
- Lymphedema, Bioimpedance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ImpediMed LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 6 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
When Lymphoedema is present, lymph and other fluids build up in the interstitial spaces of the tissues. This results in an overall increase in the total amount of extracellular fluid (ECF) in the limb, causing swelling. This can be documented by measuring the impedance (opposition) to a low frequency current that has been passed into the limb. Low frequency current travels predominantly through the ECF, where the Lymphoedema manifests. As the fluid builds up in the limb, the impedance to the current decreases and it is in this way that low frequency bioimpedance is able to assess Lymphoedema.
Multi-frequency bio-impedance analysis otherwise known as Bioimpedance Spectroscopy (BIS) has been reported to be effective for the measurement of ECF and sub clinical changes in ECF to predict the onset of Lymphoedema in the arms in studies conducted by Cornish et al. It has been reported by Warren et al that BIS can be used as a reliable and accurate tool for documenting presence of lymphoedema in patients with wither upper- or lower-extremity swelling.
The Imp™ XCA device uses an "impedance ratio" methodology to assess unilateral Lymphoedema of the arm. By this method the unaffected arm acts as an internal and subject specific control. The Imp SFB7+ (L-Dex U400) uses the same principles but at a lower frequency. This study is designed to show the equivalence of the 2 devices in assessing unilateral Lymphoedema of the arm.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1 - Primary care clinic Group 2 - Community sample
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Substantial equivalence of the SFB7+ (L-Dex U400) to XCA in the assessment Lymphoedema
Time frame: Single point measure
Observation of difference between L-Dex values of lymphoedema population compared to healthy individuals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn Box, PhD principal investigator
Queensland Lymphoedema and Breast Oncology Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema, run by ImpediMed Limited at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substantial equivalence of the SFB7+ (L-Dex U400) to XCA in the assessment Lymphoedema (time frame: Single point measure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.