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Geko Neuromuscular Stimulator vs Thromboembolism Deterrent Stockings (TEDS): DVT Prevention Study

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ClinicalTrials.gov Identifier: NCT01935414
Recruitment Status : Recruiting
First Posted : September 5, 2013
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Firstkind Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Device: geko™ post-surgery for 48hrs then 4hrs/day until discharge. Device: TEDS post-surgery for 48hrs then 4hrs/day until discharge. Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : August 2013
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: geko™
geko™ use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge
 Device: geko™ post-surgery for 48hrs then 4hrs/day until discharge.
Active Comparator: TEDS stockings
TEDS use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge
 Device: TEDS post-surgery for 48hrs then 4hrs/day until discharge.


Outcome Measures
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Primary Outcome Measures :
  1. Presence of asymptomatic DVT assessed by Duplex Ultrasound [ Time Frame: 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18 years of age and over
  2. Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders).
  3. 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.
  4. Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
  5. Able and willing to follow the protocol requirements.

Exclusion Criteria:

  1. Are requiring hip revision surgery
  2. History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
  3. Evidence of asymptomatic DVT by Duplex Ultrasound
  4. Peripheral arterial disease (ABPI < 0.8), varicose veins or lower limb ulceration or ischemia.
  5. Significant varicose veins, phlebitis or lower limb ulceration or ischemia. CEAP Grade 4-6. See Appendix 2
  6. Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).
  7. Recent trauma to lower limb.
  8. Chronic Obesity (BMI Index >40kg/m2).
  9. Pregnancy.

  10. 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

  11. On LMWH/Heparin (Prophylactic/therapeutic doses) or Warfarin or warfarin stopped recently and replaced by LMWH/ Heparin
  12. Long term steroid with dermatological changes
  13. A pulse rate of less than 40 beats/minute
  14. A sitting systolic blood pressure >180 and <100 mmHg and/or a sitting diastolic pressure of >100 mmHg.
  15. Any significant illness during the four (4) weeks preceding the hip replacement surgery.
  16. Participation in any clinical study during the eight (8) weeks preceding the screening period
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935414


Contacts
Contact: Matthew Womack, PhD +44(0) 7456427910 matthew.womack@firstkindmedical.com

Locations
United Kingdom
BMI The Harbour Hospital Recruiting
Poole, Dorset, United Kingdom, BH15 2BH
Sponsors and Collaborators
Firstkind Ltd
More Information
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Additional Information:
Company website  This link exits the ClinicalTrials.gov site

Responsible Party: Firstkind Ltd
ClinicalTrials.gov Identifier: NCT01935414     History of Changes
Other Study ID Numbers: FKD-TEDS-001
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Thrombosis
Thromboembolism
Venous Thrombosis
 Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases