Back to resultsGeko Neuromuscular Stimulator vs Thromboembolism Deterrent Stockings (TEDS): DVT Prevention Study
Primary Purpose
Deep Vein Thrombosis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
geko™ post-surgery for 48hrs then 4hrs/day until discharge.
TEDS post-surgery for 48hrs then 4hrs/day until discharge.
Sponsored by
About this trial
This is an interventional prevention trial for Deep Vein Thrombosis
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years of age and over
- Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders).
- Has not used any medications (prescribed or over-the-counter including herbal remedies) judged to be significant by the Principal Investigator during the ten (10) days preceding enrolment.
- Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
- Able and willing to follow the protocol requirements.
Exclusion Criteria:
- Are requiring hip revision surgery
- History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
- Evidence of asymptomatic DVT by Duplex Ultrasound
- Peripheral arterial disease (ABPI < 0.8), varicose veins or lower limb ulceration or ischemia.
- Significant varicose veins, phlebitis or lower limb ulceration or ischemia. CEAP Grade 4-6. See Appendix 2
- Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).
- Recent trauma to lower limb.
- Chronic Obesity (BMI Index >40kg/m2).
- Pregnancy.
Significant history of following diseases I. Cardiovascular: Recent MI (< 6 months) II. Percutaneous Coronary Intervention (PCI) with stent (< 3 months for Bare Metal Stent (BMS) and < 12 months for Drug Eluding Stent (DES) III. Moderate to severe CCF, uncontrolled AF IV. Neurological: Stroke, Hemiplegia/Paraplegia, Myopathies V. Significant dermatological conditions affecting lower limbs resulting in broken or inflamed skin particularly at the site where the device is to be fitted.
VI. Clinically significant haematological conditions i.e. coagulation disorders, sickle cell disease VII. Psychiatric disorders
- On LMWH/Heparin (Prophylactic/therapeutic doses) or Warfarin or warfarin stopped recently and replaced by LMWH/ Heparin
- Long term steroid with dermatological changes
- A pulse rate of less than 40 beats/minute
- A sitting systolic blood pressure >180 and <100 mmHg and/or a sitting diastolic pressure of >100 mmHg.
- Any significant illness during the four (4) weeks preceding the hip replacement surgery.
- Participation in any clinical study during the eight (8) weeks preceding the screening period
Sites / Locations
- BMI The Harbour Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
geko™
TEDS stockings
Arm Description
geko™ use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge
TEDS use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge
Outcomes
Primary Outcome Measures
Presence of asymptomatic DVT assessed by Duplex Ultrasound
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01935414
Brief Title
Geko Neuromuscular Stimulator vs Thromboembolism Deterrent Stockings (TEDS): DVT Prevention Study
Official Title
A Multicentre Randomised Controlled Trial Comparing the Incidence of Asymptomatic and Symptomatic Deep Vein Thrombosis Between the gekoTM Device and Thromboembolism Deterrent Stockings in Patients Recovering From Total Hip Replacement Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
November 16, 2016 (Actual)
Study Completion Date
November 16, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Firstkind Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study hypothesises that the geko™ device is more efficient than TEDS in preventing the formation of symptomatic/asymptomatic Deep Vein Thrombosis (DVTs), post-surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
geko™
Arm Type
Experimental
Arm Description
geko™ use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge
Arm Title
TEDS stockings
Arm Type
Active Comparator
Arm Description
TEDS use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge
Intervention Type
Device
Intervention Name(s)
geko™ post-surgery for 48hrs then 4hrs/day until discharge.
Intervention Type
Device
Intervention Name(s)
TEDS post-surgery for 48hrs then 4hrs/day until discharge.
Primary Outcome Measure Information:
Title
Presence of asymptomatic DVT assessed by Duplex Ultrasound
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 years of age and over
Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders).
Has not used any medications (prescribed or over-the-counter including herbal remedies) judged to be significant by the Principal Investigator during the ten (10) days preceding enrolment.
Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
Able and willing to follow the protocol requirements.
Exclusion Criteria:
Are requiring hip revision surgery
History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
Evidence of asymptomatic DVT by Duplex Ultrasound
Peripheral arterial disease (ABPI < 0.8), varicose veins or lower limb ulceration or ischemia.
Significant varicose veins, phlebitis or lower limb ulceration or ischemia. CEAP Grade 4-6. See Appendix 2
Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).
Recent trauma to lower limb.
Chronic Obesity (BMI Index >40kg/m2).
Pregnancy.
Significant history of following diseases I. Cardiovascular: Recent MI (< 6 months) II. Percutaneous Coronary Intervention (PCI) with stent (< 3 months for Bare Metal Stent (BMS) and < 12 months for Drug Eluding Stent (DES) III. Moderate to severe CCF, uncontrolled AF IV. Neurological: Stroke, Hemiplegia/Paraplegia, Myopathies V. Significant dermatological conditions affecting lower limbs resulting in broken or inflamed skin particularly at the site where the device is to be fitted.
VI. Clinically significant haematological conditions i.e. coagulation disorders, sickle cell disease VII. Psychiatric disorders
On LMWH/Heparin (Prophylactic/therapeutic doses) or Warfarin or warfarin stopped recently and replaced by LMWH/ Heparin
Long term steroid with dermatological changes
A pulse rate of less than 40 beats/minute
A sitting systolic blood pressure >180 and <100 mmHg and/or a sitting diastolic pressure of >100 mmHg.
Any significant illness during the four (4) weeks preceding the hip replacement surgery.
Participation in any clinical study during the eight (8) weeks preceding the screening period
Facility Information:
Facility Name
BMI The Harbour Hospital
City
Poole
State/Province
Dorset
ZIP/Postal Code
BH15 2BH
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.gekodevices.com/en-uk/
Description
Company website
Learn more about this trial
Geko Neuromuscular Stimulator vs Thromboembolism Deterrent Stockings (TEDS): DVT Prevention Study
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