Kidney TransplantNCT01860820
The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema
A study testing Geko device in people with Kidney Transplant and Kidney Pancreas Transplant, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients that will be randomized to one of the two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Kidney Pancreas Transplant, Edema
- What is being tested?
- Geko device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Dec 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- At least 18 years old
- Undergoing kidney or kidney pancreas transplant surgery as the recipient
- Able and willing to provide written informed consent
- Absence of known peripheral vascular disease
- Body Mass Index of between 18 and 34
- Leg circumference at site of geko™ device placement is 24" or less
Who cannot join
- History of deep vein thrombosis
- Temporary or permanent cardiac pacing
- Patient is pregnant
- Any patient which may be excluded by way of warnings in the Manufacturer's Instructions for Use
- Any patient who requires an ECG electrode applied on the leg for continuous monitoring throughout therapy
- Previous leg(s) amputation
Show all 12Show fewer
- Presence of any of the following in the site of intended device placement: cancerous lesion, swollen or infected or inflamed areas or skin eruptions i.e. phlebitis, thrombophlebitis, varicose veins
- History or signs of haematological disorders (especially in relation to clotting or coagulation disorders) including presence or history of thrombus formation
- BMI index >36
- Patients with any neurological disorder or disease that would interfere with proper assessment and or conduct of the trial
- History of implantable brain or other stimulator
- Patients who can not tolerate the stimulation from the GEKO device
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre, University Hospital
London, Ontario, N6A 5A5
About this study
This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients that will be randomized to one of the two groups. Clinical outcomes will be compared for those in each group and clinical differences between patients who receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.
Read the detailed description
This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients will be randomized to one of the two; one will receive standard of care IPC or TED stockings to help with circulation, the other group will use the geko device which is a newer device with Health Canada approval. Clinical outcomes will be compared for those in each group and clinical differences between patients who receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.
- Conditions
- Kidney Transplant, Kidney Pancreas Transplant, Edema
- Being tested
- Geko device
- Keywords
- IPC/TEDS, Geko device
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geko deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Best Medical Therapy | No intervention | Participants will follow standard post-transplant protocols with IPC |
| Geko device | Active comparator | Participants will be fitted with the device to ensure that it functions according to the manufacturer's instructions by a trained technician. This device will be changed every 24 hours. The device is worn on both legs and is worn for 24 hours a day. The device will first be put on the first day following the day of surgery and will then be changed the following day at the same time for a total of 7 days after surgery. Receives: Device: Geko device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in edema
As measured by patient weight and leg diameter
Measured: Within 30 days post-transplant
Secondary outcomes (1)
Patient satisfaction
Patients will be asked to complete a questionnaire at these time points to assess their satisfaction
Measured: 3 and 6 days after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startJun 2015
- Primary completionSep 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alp Sener, MD, Principal investigator, Lawson Health Research Institute, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860820
- Sponsor's protocol ID
- 103618
- Status last verified
- Oct 2021
- First submitted
- 21 May 2013
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema
- ClinicalTrials.gov ID
- NCT01860820
- Acronym / sponsor ID
- 103618
- Conditions
- Kidney Transplant, Kidney Pancreas Transplant, Edema
- Keywords
- IPC/TEDS, Geko device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 23 May 2013 (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.
This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients that will be randomized to one of the two groups. Clinical outcomes will be compared for those in each group and clinical differences between patients who receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.
Detailed description
This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients will be randomized to one of the two; one will receive standard of care IPC or TED stockings to help with circulation, the other group will use the geko device which is a newer device with Health Canada approval. Clinical outcomes will be compared for those in each group and clinical differences between patients who receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best Medical Therapy | No intervention | –Participants will follow standard post-transplant protocols with IPC |
| Geko device | Active comparator | Device: Geko deviceParticipants will be fitted with the device to ensure that it functions according to the manufacturer's instructions by a trained technician. This device will be changed every 24 hours. The device is worn on both legs and is worn for 24 hours a day. The device will first be put on the first day following the day of surgery and will then be changed the following day at the same time for a total of 7 days after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female
- At least 18 years old
- Undergoing kidney or kidney pancreas transplant surgery as the recipient
- Able and willing to provide written informed consent
- Absence of known peripheral vascular disease
Key exclusion criteria (12 listed)
- History of deep vein thrombosis
- Temporary or permanent cardiac pacing
- Patient is pregnant
- Any patient which may be excluded by way of warnings in the Manufacturer's Instructions for Use
- Any patient who requires an ECG electrode applied on the leg for continuous monitoring throughout therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geko device | Device | Geko device |
Primary outcome
Decrease in edema
Time frame: Within 30 days post-transplant
As measured by patient weight and leg diameter
1 secondary outcome
Patient satisfaction
Time frame: 3 and 6 days after transplant
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 25 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Alp Sener, MD principal investigator
Lawson Health Research Institute, London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geko device in people with Kidney Transplant and Kidney Pancreas Transplant, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 7 inclusion and 12 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 25 Oct 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 Canada. 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?
Decrease in edema (time frame: Within 30 days post-transplant). 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 25 Oct 2021.