Edema LegCTR-Edema-USNCT04700735
Cross Therapy Registry - Edema - US
An observational study of Edema Leg, run by Firstkind Ltd at 3 sites in United States.
Trial summary
The geko™ Cross Therapy Registry - Edema (gekoTM CTR - Edema) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edema Leg
- What is being tested?
- geko Neuromuscular Electro Stimulator (NMES)
- Type of treatment
- Medical device
- How many people
- 83 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Jun 2021to 9 Nov 2023
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Participants who have been identified to receive gekoTM therapy as part of their standard care for edema reduction.
Who may be able to join
- Male or female aged ≥ 18 years and able to provide written informed consent.
- Intact healthy skin at the site of gekoTM device application.
- Subjects receiving gekoTM therapy as part of their standard care for edema reduction.
Who cannot join
- Pregnancy or breast feeding.
- Use of any concurrent neuro-modulation device.
- Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
- No involuntary movement of the lower leg/foot at the maximum tolerable device setting.
- Bilateral lower limb surgical intervention.
- Unicondylar knee replacement surgical intervention.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Luminis Health Research Institute
Annapolis, Maryland, 21401
JIS Orthopedics
New Albany, Ohio, 43054
Genesee Orthopedics
New Hartford, New York, 13413
About this study
Official title: Cross Therapy Registry - Edema Post Market Clinical Follow-up of Safety and Patient Outcomes for Subjects Undergoing Peroneal Nerve Stimulation by Geko™.
The geko™ Cross Therapy Registry - Edema (gekoTM CTR - Edema) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months.
Read the detailed description
The geko™ device has a wide range of clinical applications including the post-operative management of edema.
Although many short-term acute studies have been completed using the device, little clinical data has been collected on the effect of geko™ use in current standard care pathways for edema management on patient outcomes during follow-up of up to twelve months.
As the manufacturer of the device, Firstkind Limited has an obligation to collect safety and performance data to comply with current regulations (MDR EU 2017/745 Annex XIV, Part B). Consequently, there is a need for an observational study to provide data to demonstrate patient benefit and regulatory compliance.
The geko™ Cross Therapy Registry - Edema (gekoTM CTR - Edema) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months. This study forms part of the overall Post-Market Clinical Follow-up strategy for the device and Post Market Surveillance (PMS) to support device and performance.
- Conditions
- Edema Leg
- Being tested
- geko Neuromuscular Electro Stimulator (NMES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
geko Neuromuscular Electro Stimulator (NMES)Device
Neuromuscular Electro Stimulator (NMES)
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety: determine frequency of adverse events (AEs) and serious AEs (SAEs) whether device related or not and compare rate to historic and published data i.e. gekoTM vs standard of care (SC).
Measured: One year
Performance
Performance: determine frequency of Device Deficiencies (DD) and compare rate to historic and published data i.e. gekoTM vs SC.
Measured: One year
Secondary outcomes (2)
Summary of routinely collected performance data
Summarize routinely tested and collected performance data, such as patient reported outcome measures and compare to historic and published data i.e. gekoTM vs SC.
Measured: One Year
Summary of Health Economic Impact
Summarize health economic impact of gekoTM device on patient outcomes in comparison to SC.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start22 Jun 2021
- Primary completion31 Aug 2023
- Study completion9 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Edema LegStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Firstkind Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Berend, MD, Principal investigator, JIS Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700735
- Sponsor's protocol ID
- FSK-REG-001-US
- Acronym
- CTR-Edema-US
- Status last verified
- Feb 2024
- First submitted
- 6 Jan 2021
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tucker A, Maass A, Bain D, Chen LH, Azzam M, Dawson H, Johnston A. Augmentation of venous, arterial and microvascular blood supply in the leg by isometric neuromuscular stimulation via the peroneal nerve. Int J Angiol. 2010 Spring;19(1):e31-7. doi: 10.1055/s-0031-1278361.
PubMed 22477572Jawad H, Bain DS, Dawson H, Crawford K, Johnston A, Tucker A. The effectiveness of a novel neuromuscular electrostimulation method versus intermittent pneumatic compression in enhancing lower limb blood flow. J Vasc Surg Venous Lymphat Disord. 2014 Apr;2(2):160-5. doi: 10.1016/j.jvsv.2013.10.052. Epub 2014 Jan 28.
PubMed 26993181Warwick DJ, Shaikh A, Gadola S, Stokes M, Worsley P, Bain D, Tucker AT, Gadola SD. Neuromuscular electrostimulation viathe common peroneal nerve promotes lower limb blood flow in a below-kneecast: A potential for thromboprophylaxis. Bone Joint Res. 2013 Sep 2;2(9):179-85. doi: 10.1302/2046-3758.29.2000176. Print 2013.
PubMed 23999610Williams KJ, Moore HM, Davies AH. Haemodynamic changes with the use of neuromuscular electrical stimulation compared to intermittent pneumatic compression. Phlebology. 2015 Jun;30(5):365-72. doi: 10.1177/0268355514531255. Epub 2014 Apr 10.
PubMed 24722790Zhang Q, Styf J, Ekstrom L, Holm AK. Effects of electrical nerve stimulation on force generation, oxygenation and blood volume in muscles of the immobilized human leg. Scand J Clin Lab Invest. 2014 Aug;74(5):369-77. doi: 10.3109/00365513.2014.898323. Epub 2014 Apr 3.
PubMed 24697619Yilmaz S, Calbiyik M, Yilmaz BK, Aksoy E. Potential role of electrostimulation in augmentation of venous blood flow after total knee replacement: A pilot study. Phlebology. 2016 May;31(4):251-6. doi: 10.1177/0268355515580473. Epub 2015 Apr 6.
PubMed 25852131Griffin M, Bond D, Nicolaides A. Measurement of blood flow in the deep veins of the lower limb using the geko neuromuscular electro-stimulation device. Int Angiol. 2016 Aug;35(4):406-10. Epub 2016 Mar 2.
PubMed 26934561Barnes R, Madden LA, Chetter IC. Fibrinolytic effects of peroneal nerve stimulation in patients with lower limb vascular disease. Blood Coagul Fibrinolysis. 2016 Apr;27(3):275-80. doi: 10.1097/MBC.0000000000000409.
PubMed 26397885Wainwright TW, Burgess LC, Middleton RG. A feasibility randomised controlled trial to evaluate the effectiveness of a novel neuromuscular electro-stimulation device in preventing the formation of oedema following total hip replacement surgery. Heliyon. 2018 Jul 18;4(7):e00697. doi: 10.1016/j.heliyon.2018.e00697. eCollection 2018 Jul.
PubMed 30094367Mahmood, Ihsan FRCS (T&O); Chandler, Henry MRCS; Kottam, Lucksy PhD; Eardley, William FRCS (T&O); Rangan, Amar FRCS (T&O); Baker, Paul FRCS (T&O) Neuromuscular Electrostimulation Device Reduces Preoperative Edema and Accelerates Readiness for Theater in Patients Requiring Open Reduction Internal Fixation for Acute Ankle Fracture, Techniques in Foot & Ankle Surgery: December 2020 - Volume 19 - Issue 4 - p 215-219 doi: 10.1097/BTF.0000000000000257
Jones NJ, Ivins N, Ebdon V, Hagelstein S, Harding KG. Neuromuscular electrostimulation on lower limb wounds. Br J Nurs. 2018 Nov 8;27(20):S16-S21. doi: 10.12968/bjon.2018.27.Sup20.S16.
PubMed 30418851Harris C, Duong R, Vanderheyden G, Byrnes B, Cattryse R, Orr A, Keast D. Evaluation of a muscle pump-activating device for non-healing venous leg ulcers. Int Wound J. 2017 Dec;14(6):1189-1198. doi: 10.1111/iwj.12784. Epub 2017 Aug 2.
PubMed 28770561Harris C, Ramage D, Boloorchi A, Vaughan L, Kuilder G, Rakas S. Using a muscle pump activator device to stimulate healing for non-healing lower leg wounds in long-term care residents. Int Wound J. 2019 Feb;16(1):266-274. doi: 10.1111/iwj.13027. Epub 2018 Nov 20.
PubMed 30460740Pichonnaz C, Bassin JP, Lecureux E, Currat D, Jolles BM. Bioimpedance spectroscopy for swelling evaluation following total knee arthroplasty: a validation study. BMC Musculoskelet Disord. 2015 Apr 25;16:100. doi: 10.1186/s12891-015-0559-5.
PubMed 25907994Loyd BJ, Kittelson AJ, Forster J, Stackhouse S, Stevens-Lapsley J. Development of a reference chart to monitor postoperative swelling following total knee arthroplasty. Disabil Rehabil. 2020 Jun;42(12):1767-1774. doi: 10.1080/09638288.2018.1534005. Epub 2019 Jan 22.
PubMed 30668214
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Therapy Registry - Edema Post Market Clinical Follow-up of Safety and Patient Outcomes for Subjects Undergoing Peroneal Nerve Stimulation by Geko™.
- ClinicalTrials.gov ID
- NCT04700735
- Acronym / sponsor ID
- CTR-Edema-US / FSK-REG-001-US
- Conditions
- Edema Leg
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Firstkind LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 8 Jan 2021 (actual)
- 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 geko™ Cross Therapy Registry - Edema (gekoTM CTR - Edema) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months.
Detailed description
The geko™ device has a wide range of clinical applications including the post-operative management of edema.
Although many short-term acute studies have been completed using the device, little clinical data has been collected on the effect of geko™ use in current standard care pathways for edema management on patient outcomes during follow-up of up to twelve months.
As the manufacturer of the device, Firstkind Limited has an obligation to collect safety and performance data to comply with current regulations (MDR EU 2017/745 Annex XIV, Part B). Consequently, there is a need for an observational study to provide data to demonstrate patient benefit and regulatory compliance.
The geko™ Cross Therapy Registry - Edema (gekoTM CTR - Edema) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months. This study forms part of the overall Post-Market Clinical Follow-up strategy for the device and Post Market Surveillance (PMS) to support device and performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants who have been identified to receive gekoTM therapy as part of their standard care for edema reduction.
Key inclusion criteria (3 listed)
- Male or female aged ≥ 18 years and able to provide written informed consent.
- Intact healthy skin at the site of gekoTM device application.
- Subjects receiving gekoTM therapy as part of their standard care for edema reduction.
Key exclusion criteria (6 listed)
- Pregnancy or breast feeding.
- Use of any concurrent neuro-modulation device.
- Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
- No involuntary movement of the lower leg/foot at the maximum tolerable device setting.
- Bilateral lower limb surgical intervention.
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 Neuromuscular Electro Stimulator (NMES)Neuromuscular Electro Stimulator (NMES) | Device | – |
Primary outcome
Safety
Time frame: One year
Safety: determine frequency of adverse events (AEs) and serious AEs (SAEs) whether device related or not and compare rate to historic and published data i.e. gekoTM vs standard of care (SC).
Performance
Time frame: One year
Performance: determine frequency of Device Deficiencies (DD) and compare rate to historic and published data i.e. gekoTM vs SC.
2 secondary outcomes
Summary of routinely collected performance data
Time frame: One Year
Summary of Health Economic Impact
Time frame: One year
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 1 Mar 2024.
- Background: PubMed 22477572Tucker A, Maass A, Bain D, Chen LH, Azzam M, Dawson H, Johnston A. Augmentation of venous, arterial and microvascular blood supply in the leg by isometric neuromuscular stimulation via the peroneal nerve. Int J Angiol. 2010 Spring;19(1):e31-7. doi: 10.1055/s-0031-1278361.
- Background: PubMed 26993181Jawad H, Bain DS, Dawson H, Crawford K, Johnston A, Tucker A. The effectiveness of a novel neuromuscular electrostimulation method versus intermittent pneumatic compression in enhancing lower limb blood flow. J Vasc Surg Venous Lymphat Disord. 2014 Apr;2(2):160-5. doi: 10.1016/j.jvsv.2013.10.052. Epub 2014 Jan 28.
- Background: PubMed 23999610Warwick DJ, Shaikh A, Gadola S, Stokes M, Worsley P, Bain D, Tucker AT, Gadola SD. Neuromuscular electrostimulation viathe common peroneal nerve promotes lower limb blood flow in a below-kneecast: A potential for thromboprophylaxis. Bone Joint Res. 2013 Sep 2;2(9):179-85. doi: 10.1302/2046-3758.29.2000176. Print 2013.
- Background: PubMed 24722790Williams KJ, Moore HM, Davies AH. Haemodynamic changes with the use of neuromuscular electrical stimulation compared to intermittent pneumatic compression. Phlebology. 2015 Jun;30(5):365-72. doi: 10.1177/0268355514531255. Epub 2014 Apr 10.
- Background: PubMed 24697619Zhang Q, Styf J, Ekstrom L, Holm AK. Effects of electrical nerve stimulation on force generation, oxygenation and blood volume in muscles of the immobilized human leg. Scand J Clin Lab Invest. 2014 Aug;74(5):369-77. doi: 10.3109/00365513.2014.898323. Epub 2014 Apr 3.
- Background: PubMed 25852131Yilmaz S, Calbiyik M, Yilmaz BK, Aksoy E. Potential role of electrostimulation in augmentation of venous blood flow after total knee replacement: A pilot study. Phlebology. 2016 May;31(4):251-6. doi: 10.1177/0268355515580473. Epub 2015 Apr 6.
- Background: PubMed 26934561Griffin M, Bond D, Nicolaides A. Measurement of blood flow in the deep veins of the lower limb using the geko neuromuscular electro-stimulation device. Int Angiol. 2016 Aug;35(4):406-10. Epub 2016 Mar 2.
- Background: PubMed 26397885Barnes R, Madden LA, Chetter IC. Fibrinolytic effects of peroneal nerve stimulation in patients with lower limb vascular disease. Blood Coagul Fibrinolysis. 2016 Apr;27(3):275-80. doi: 10.1097/MBC.0000000000000409.
- Background: PubMed 30094367Wainwright TW, Burgess LC, Middleton RG. A feasibility randomised controlled trial to evaluate the effectiveness of a novel neuromuscular electro-stimulation device in preventing the formation of oedema following total hip replacement surgery. Heliyon. 2018 Jul 18;4(7):e00697. doi: 10.1016/j.heliyon.2018.e00697. eCollection 2018 Jul.
- BackgroundMahmood, Ihsan FRCS (T&O); Chandler, Henry MRCS; Kottam, Lucksy PhD; Eardley, William FRCS (T&O); Rangan, Amar FRCS (T&O); Baker, Paul FRCS (T&O) Neuromuscular Electrostimulation Device Reduces Preoperative Edema and Accelerates Readiness for Theater in Patients Requiring Open Reduction Internal Fixation for Acute Ankle Fracture, Techniques in Foot & Ankle Surgery: December 2020 - Volume 19 - Issue 4 - p 215-219 doi: 10.1097/BTF.0000000000000257
- Background: PubMed 30418851Jones NJ, Ivins N, Ebdon V, Hagelstein S, Harding KG. Neuromuscular electrostimulation on lower limb wounds. Br J Nurs. 2018 Nov 8;27(20):S16-S21. doi: 10.12968/bjon.2018.27.Sup20.S16.
- Background: PubMed 28770561Harris C, Duong R, Vanderheyden G, Byrnes B, Cattryse R, Orr A, Keast D. Evaluation of a muscle pump-activating device for non-healing venous leg ulcers. Int Wound J. 2017 Dec;14(6):1189-1198. doi: 10.1111/iwj.12784. Epub 2017 Aug 2.
- 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.
Keith Berend, MD principal investigator
JIS Orthopedics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edema Leg, run by Firstkind Ltd at 3 sites in United States.
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 3 inclusion and 6 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 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Safety (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04700735, which also lists 17 linked publications.
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 1 Mar 2024.