The Equivalency of the Imp SFB7+ (L-Dex U400) With the Imp XCA Device

NCT00766935 | Completed

• 1 other identifier: UQSFB7+-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema

Keywords

Lymphedema; Bioimpedance

Outcome Measures

Primary Outcomes (1)

• 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

  Single point measure

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group 1 - Primary care clinic Group 2 - Community sample

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ImpediMed Limited: lead

Study Sites (1)

Queensland Lymphoedema and Breast Oncology Physiotherapy

Brisbane, Queensland, 4032, Australia

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Robyn Box, PhD

  Queensland Lymphoedema and Breast Oncology Physiotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 6, 2008
• Study Start: November 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: April 1, 2008
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

AU (1)