C.Surgical Procedure; Vascular (Peripheral)Phase 1NCT01625481
Seal-V Safety and Performance Study
A Phase 1 study testing Seal-V in people with C.Surgical Procedure; Vascular (Peripheral), run by Sealantis Ltd. at 3 sites in Israel.
Trial summary
The purpose of this study is to further assess the safety and performance of Seal-V as an adjunct to standard surgical procedure for achieving hemostasis in patients undergoing peripheral vascular reconstruction surgeries using synthetic grafts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- C.Surgical Procedure; Vascular (Peripheral)
- What is being tested?
- Seal-V
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 3 sitesIsrael
- Study dates
- Jul 2012to Mar 2014
- Phase
- Phase 1
- 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
- Male or female of >18 years of age
- Signed Informed Consent
- Patients requiring vascular reconstruction surgeries using synthetic (such as PTFE, Dacron) or autologous (such as native veins) grafts, including the following:
- Peripheral bypass surgeries, such as arterio-arterial bypasses [including: axillo-(bi)femoral, ilio-(bi)femoral, femoro-femoral, ilio-popliteal, femoro-popliteal (including below knee), femoro-tibial vessel bypass]
- Arteriovenous (AV) dialysis access shunt in the upper or lower extremity
- Patients able and willing to complete all follow-up visits
Who cannot join
- Vascular surgery other than peripheral bypass surgeries and arteriovenous (AV) dialysis access shunt procedures as described above
- Reoperation at the same treatment site
- Known sensitivity to device materials, such as indigo carmine dye or alginate
- Pregnant or lactating women
- Systemic infection
- Participation in another clinical trial or treatment with any investigational agent in past 30 days
Show all 13Show fewer
- Congenital coagulation disorders (e.g., thrombocytopenia [<100,000 platelet count], thromboasthenia, hemophilia, or von Willebrand disease)
- Severe congenital or acquired immunodeficiency (e.g., HIV infection or long term treatment with immunosuppressive drugs)
- Prior radiation therapy to the operating field
- Intraoperative Exclusion Criteria:
- Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
- Intraoperative change in planned surgical procedure that results in the patient no longer meeting preoperative inclusion and/or exclusion criteria
- Local infection at the operating field
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Department of Vascular Surgery, Bnai-Zion Medical Center
Haifa
Vascular Surgery Department, Rambam Health Care
Haifa
Department of Vascular Surgery, Chaim Sheba Medical Center
Tel HaShomer, 52621
About this study
Official title: Prospective, Single Arm, Open Label, Non-randomized Study to Evaluate The Safety and Performance of The Seal-V System
The purpose of this study is to further assess the safety and performance of Seal-V as an adjunct to standard surgical procedure for achieving hemostasis in patients undergoing peripheral vascular reconstruction surgeries using synthetic grafts.
- Being tested
- Seal-V
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seal-VDevice
Also called SEAlantis Vascular WP2(A)
Seal-V is applied adjunctively to cover the suture lines.
| Study group | Role | What they receive |
|---|---|---|
| Seal-V | Experimental | A vascular sealant intended to achieve adjunctive hemostasis by mechanically sealing areas of potential leakage in surgical reconstruction of large blood vessels. Receives: Device: Seal-V |
What is being measured
The primary outcome is the main question the study is designed to answer.
TTH, Time to Hemostasis
Duration from the point at which circulation is restored to the graft/artery until bleeding ceases at the treatment site
Measured: Perioperative; within 10 minutes after clamp release
Secondary outcomes (3)
Successful cessation of bleeding at a treatment site
Measured: Perioperative; within 10 minutes after clamp release
Intraoperative blood loss
Measured by weighing the surgical swabs used only in the application area and used from the time Seal-V was applied until hemostasis
Measured: Perioperative
Incidence of successful deployment of the Seal-V device
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C.Surgical Procedure; Vascular (Peripheral)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sealantis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rina Lev, PhD, Study director, Sealantis Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625481
- Sponsor's protocol ID
- WP2-072-02
- Status last verified
- May 2014
- First submitted
- 19 Jun 2012
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm, Open Label, Non-randomized Study to Evaluate The Safety and Performance of The Seal-V System
- ClinicalTrials.gov ID
- NCT01625481
- Acronym / sponsor ID
- WP2-072-02
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Sealantis Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 21 Jun 2012 (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 purpose of this study is to further assess the safety and performance of Seal-V as an adjunct to standard surgical procedure for achieving hemostasis in patients undergoing peripheral vascular reconstruction surgeries using synthetic grafts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seal-V | Experimental | Device: Seal-VA vascular sealant intended to achieve adjunctive hemostasis by mechanically sealing areas of potential leakage in surgical reconstruction of large blood vessels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female of >18 years of age
- Signed Informed Consent
- Patients requiring vascular reconstruction surgeries using synthetic (such as PTFE, Dacron) or autologous (such as native veins) grafts, including the following:
- Peripheral bypass surgeries, such as arterio-arterial bypasses [including: axillo-(bi)femoral, ilio-(bi)femoral, femoro-femoral, ilio-popliteal, femoro-popliteal (including below knee), femoro-tibial vessel bypass]
- Arteriovenous (AV) dialysis access shunt in the upper or lower extremity
Key exclusion criteria (13 listed)
- Vascular surgery other than peripheral bypass surgeries and arteriovenous (AV) dialysis access shunt procedures as described above
- Reoperation at the same treatment site
- Known sensitivity to device materials, such as indigo carmine dye or alginate
- Pregnant or lactating women
- Systemic infection
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 |
|---|---|---|
| Seal-VAlso: SEAlantis Vascular WP2(A)Seal-V is applied adjunctively to cover the suture lines. | Device | Seal-V |
Primary outcome
TTH, Time to Hemostasis
Time frame: Perioperative; within 10 minutes after clamp release
Duration from the point at which circulation is restored to the graft/artery until bleeding ceases at the treatment site
3 secondary outcomes
Successful cessation of bleeding at a treatment site
Time frame: Perioperative; within 10 minutes after clamp release
Intraoperative blood loss
Time frame: Perioperative
Incidence of successful deployment of the Seal-V device
Time frame: Perioperative
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 28 May 2014.
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.
Rina Lev, PhD study director
Sealantis Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Seal-V in people with C.Surgical Procedure; Vascular (Peripheral), run by Sealantis Ltd. at 3 sites 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 13 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 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
TTH, Time to Hemostasis (time frame: Perioperative; within 10 minutes after clamp release). 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 28 May 2014.