We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00805831
First Posted: December 10, 2008
Last Update Posted: July 7, 2010
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.
Information provided by:
HDH Medical Ltd
  Purpose
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 Intervention
Vascular Disease Atherosclerosis Device: HDH

Study Type: Interventional
Study Design: 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

Further study details as provided by HDH Medical Ltd:

Primary Outcome Measures:
  • 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:
  • Time to complete the anastomosis [ Time Frame: during the surgery ]

Estimated Enrollment: 10
Study Start Date: October 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Aortic anastomosis surgery will be conducted using HDH device.
Device: HDH
sutureless vascular anastomosis

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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/
  Contacts and Locations
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
Israel
Barzilai Medical center
Ashkelon, Israel, 78278
Sponsors and Collaborators
HDH Medical Ltd
Investigators
Principal Investigator: Boris Yofee, MD Barzilai Medical Center, Ashkelon, Israel
  More Information

Responsible Party: Dr. Hanna Levy, Clinical Study Consultant, Qsite
ClinicalTrials.gov Identifier: NCT00805831     History of Changes
Other Study ID Numbers: HDH -AAA-P-01
First Submitted: December 9, 2008
First Posted: December 10, 2008
Last Update Posted: July 7, 2010
Last Verified: July 2010

Keywords provided by HDH Medical Ltd:
sutureless vascular bypass

Additional relevant MeSH terms:
Atherosclerosis
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases