Vascular DiseaseNCT00805831
Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis
A study testing HDH in people with Vascular Disease and Atherosclerosis, run by HDH Medical Ltd at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Disease, Atherosclerosis
- What is being tested?
- HDH
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2008to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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/
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Vascular Disease, Atherosclerosis
- Being tested
- HDH
- Keywords
- sutureless vascular bypass
- Medical subject headings
- Vascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDHDevice
sutureless vascular anastomosis
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Aortic anastomosis surgery will be conducted using HDH device. Receives: Device: HDH |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish safety of using the HDH device for creating sutureless aortic anastomosis. Safety will be established by lack of serious adverse events.
Measured: within 1 month
Secondary outcomes (1)
Time to complete the anastomosis
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HDH Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boris Yofee, MD, Principal investigator, Barzilai Medical Center, Ashkelon, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805831
- Sponsor's protocol ID
- HDH -AAA-P-01
- Status last verified
- Jul 2010
- First submitted
- 9 Dec 2008
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis
- ClinicalTrials.gov ID
- NCT00805831
- Acronym / sponsor ID
- HDH -AAA-P-01
- Conditions
- Vascular Disease, Atherosclerosis
- Keywords
- sutureless vascular bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- HDH Medical LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: HDHAortic anastomosis surgery will be conducted using HDH device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDHsutureless vascular anastomosis | Device | A |
Primary outcome
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
1 secondary outcome
Time to complete the anastomosis
Time frame: during the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Yofee, MD principal investigator
Barzilai Medical Center, Ashkelon, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HDH in people with Vascular Disease and Atherosclerosis, run by HDH Medical Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2010.