Study Stopped
No funding
Surgical Revascularisation and Nerve Stimulation Trial
SRANS
A Randomised Control Trial to Establish if Use of the gekoTM (Trademark) Post Infra-inguinal Surgical Vein Revascularisation Increases Flow Through the Graft
1 other identifier
interventional
N/A
1 country
1
Brief Summary
A study to investigate if the gekoTM device improves flow through vascular bypass grafts
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 5, 2013
CompletedFirst Posted
Study publicly available on registry
September 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJuly 15, 2019
July 1, 2019
1.2 years
September 5, 2013
July 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in arterial blood volume flow in the bypass graft measured by ultrasound.
Measured by ultrasound duplex
1 day
Secondary Outcomes (7)
To assess effect on blood flow in the superficial femoral vein
1 day
To assess effect on microcirculation
1 day
To assess effect on pulse wave velocity, cardiac output and stroke volume
1 day
To assess effect on levels of VEGF, PAI-1 and tPA antigen.
1 day
To assess the impact of gekoTM device on pain score utilising the McGill Pain score
1 day
- +2 more secondary outcomes
Study Arms (2)
No intervention
NO INTERVENTIONNo intervention
GekoTM
ACTIVE COMPARATORgeko applied to bypass limb
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥18 years,
- Undergoing infra-inguinal vein bypass graft.
- Intact cutaneous sensations to nociception in the lower limb, as determined by the investigator.
- Intact healthy skin at site of application.
- On effective contraception if sexually active - oral contraceptive pill (\> 3 months use), condoms, intrauterine contraceptive device, depot injection.
- Able to understand the Patient Information Sheet and capable and willing to give informed consent and follow the protocol requirements
You may not qualify if:
- History of haematological disorder or DVT within the preceding 6 months,
- Pregnant or planning to become pregnant during study duration,
- Pacemakers or implantable defibrillators,
- Use of any other neuro-modulation device,
- Current use of TENS in pelvic region, back or legs,
- Use of investigational drug/device therapy within past 4 weeks that may interfere with this study,
- Significant varicose veins or lower limb ulceration.
- Recent surgery (such as abdominal, gynaecological, hip knee replacement).
- Recent trauma to lower limbs.
- Chronic Obesity (BMI Index \>34).
- Any medication judged to be significant by the Principal Investigator.
- Any significant illness during the four (4) weeks preceding the screening period of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hull Royal Infirmary
Hull, EastRiding of Yorkshire, HU3 2JZ, United Kingdom
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
Rachel Barnes, MRCS, MA
Hull Royal Infirmary
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2013
First Posted
September 10, 2013
Study Start
September 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
July 15, 2019
Record last verified: 2019-07