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Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00805831
Recruitment Status : Completed
First Posted : December 10, 2008
Last Update Posted : July 7, 2010
Sponsor:
Information provided by:
HDH Medical Ltd

Brief Summary:
The HDH device is intended for creating sutureless vascular anastomosis in various blood vessels. The HDH device consists of four parts: an elastic tube (graft), docking head (anastomotic device), inversion device (connects the vascular graft to HDH) and measuring device. This study was design in order to evaluate the safety and efficacy of using HDH device and method an innovative anastomotic device for sutureless aortic anastomosis in patient diagnosed with abdominal aneurysm or Aorto-iliac aneurysm.

Condition or disease Intervention/treatment Phase
Vascular Disease Atherosclerosis Device: HDH Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis
Study Start Date : October 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Experimental: A
Aortic anastomosis surgery will be conducted using HDH device.
Device: HDH
sutureless vascular anastomosis




Primary Outcome Measures :
  1. To establish safety of using the HDH device for creating sutureless aortic anastomosis. Safety will be established by lack of serious adverse events. [ Time Frame: within 1 month ]

Secondary Outcome Measures :
  1. Time to complete the anastomosis [ Time Frame: during the surgery ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patient age above 18 (men and woman)
  • Patient suffers from infrarenal abdominal aortic or Aorto-iliac aneurysm
  • Aneurysm diameter is larger than 5cm/ its annual growth is more than 0.5cm/or iliac aneurysm size is larger than 2.5cm
  • The abdominal aneurysm neck is longer than 1.5 cm
  • Patient's physical condition allows performing general anesthesia
  • Patient is willing to sign the informed consent and follow the study protocol.

Exclusion Criteria:

  • Patient Age under 18 years
  • Patient's physical condition dose not allows to perform general anesthesia
  • Patient's with terminal disease and life expectancy of less than 3 months
  • Patient objects to the treatment or study protocol
  • Anesthesiologist or personal care physician object
  • Patient suffer from Supra/infrarenal AAA
  • The abdominal aneurysm neck is smaller than 1.5 cm
  • Aneurysm diameter is smaller than 5cm/ its annual growth is less than 0.5cm/

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): NCT00805831


Locations
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Israel
Barzilai Medical center
Ashkelon, Israel, 78278
Sponsors and Collaborators
HDH Medical Ltd
Investigators
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Principal Investigator: Boris Yofee, MD Barzilai Medical Center, Ashkelon, Israel
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Responsible Party: Dr. Hanna Levy, Clinical Study Consultant, Qsite
ClinicalTrials.gov Identifier: NCT00805831    
Other Study ID Numbers: HDH -AAA-P-01
First Posted: December 10, 2008    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010
Keywords provided by HDH Medical Ltd:
sutureless vascular bypass
Additional relevant MeSH terms:
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Atherosclerosis
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases