Vascular DiseasesNCT03374735
First In-human Use of SETALUM™ Sealant: The BlueSeal Clinical Study
A study testing SETALUM™ Sealant in people with Vascular Diseases, run by Gecko Biomedical.
Trial summary
This is a prospective, multicenter, single-arm trial to evaluate the safety and performance of SETALUM™ Sealant in sealing suture lines at the anastomosis between native vessels and synthetic ePTFE vascular patch used during open vascular surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- SETALUM™ Sealant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2016to 3 Oct 2017
- 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
- ≥18 years old;
- Surgical placement of an ePTFE patch for large carotid repair;
- Written informed consent given by the patient.
Who cannot join
- Known or suspected allergy or sensitivity to any test materials or reagents;
- Concomitant intake of immunosuppressive medications;
- Prior radiation therapy to the operating field;
- Previous surgical procedure performed on the same operating field;
- Current or recent (<3months) participation in another investigational study;
- Refusal to receive blood products;
- Pregnant or breast-feeding women
About this study
Official title: Prospective, Multicenter, Non-controlled Study, Evaluating Safety and Performance of SETALUM™ Sealant as an add-on to Suture in Vascular Reconstruction in Patients Undergoing Carotid Enlargement Procedure Using an ePTFE Patch.
This is a prospective, multicenter, single-arm trial to evaluate the safety and performance of SETALUM™ Sealant in sealing suture lines at the anastomosis between native vessels and synthetic ePTFE vascular patch used during open vascular surgery.
- Conditions
- Vascular Diseases
- Being tested
- SETALUM™ Sealant
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SETALUM™ SealantDevice
SETALUM™ Sealant to be applied on the suture line
| Study group | Role | What they receive |
|---|---|---|
| SETALUM™ Sealant | Experimental | SETALUM™ Sealant to be applied on the suture line Receives: Device: SETALUM™ Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elapsed time from clamp release to hemostasis at the suture line
The hemostasis is observed by the operating surgeon and timed by an operative room nurse.
Anastomotic hemostasis is defined as an anastomosis not requiring any additional intervention to control bleeding.
Measured: During surgical procedure
All adverse events occurring from the surgical procedure to Week 12
Each Adverse Event was described by the seriouness and the nature of its relationship to the SETALUM™ Sealant or to the surgical procedure. The Data Monitoring Committee reviewed all occurred adverse events and provided a conclusion on the SETALUM™ Sealant safety profile.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start15 Mar 2016
- Primary completion7 Feb 2017
- Study completion3 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gecko Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374735
- Sponsor's protocol ID
- GB02-CL-1401
- Status last verified
- Dec 2017
- First submitted
- 5 Dec 2017
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Non-controlled Study, Evaluating Safety and Performance of SETALUM™ Sealant as an add-on to Suture in Vascular Reconstruction in Patients Undergoing Carotid Enlargement Procedure Using an ePTFE Patch.
- ClinicalTrials.gov ID
- NCT03374735
- Acronym / sponsor ID
- GB02-CL-1401
- Conditions
- Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Gecko BiomedicalIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 15 Dec 2017 (actual)
- 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.
This is a prospective, multicenter, single-arm trial to evaluate the safety and performance of SETALUM™ Sealant in sealing suture lines at the anastomosis between native vessels and synthetic ePTFE vascular patch used during open vascular surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SETALUM™ Sealant | Experimental | Device: SETALUM™ SealantSETALUM™ Sealant to be applied on the suture line |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years old;
- Surgical placement of an ePTFE patch for large carotid repair;
- Written informed consent given by the patient.
Key exclusion criteria (7 listed)
- Known or suspected allergy or sensitivity to any test materials or reagents;
- Concomitant intake of immunosuppressive medications;
- Prior radiation therapy to the operating field;
- Previous surgical procedure performed on the same operating field;
- Current or recent (<3months) participation in another investigational study;
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 |
|---|---|---|
| SETALUM™ SealantSETALUM™ Sealant to be applied on the suture line | Device | SETALUM™ Sealant |
Primary outcome
Elapsed time from clamp release to hemostasis at the suture line
Time frame: During surgical procedure
The hemostasis is observed by the operating surgeon and timed by an operative room nurse. Anastomotic hemostasis is defined as an anastomosis not requiring any additional intervention to control bleeding.
All adverse events occurring from the surgical procedure to Week 12
Time frame: Week 12
Each Adverse Event was described by the seriouness and the nature of its relationship to the SETALUM™ Sealant or to the surgical procedure. The Data Monitoring Committee reviewed all occurred adverse events and provided a conclusion on the SETALUM™ Sealant safety profile.
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 15 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SETALUM™ Sealant in people with Vascular Diseases, run by Gecko Biomedical.
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 3 inclusion and 7 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 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Elapsed time from clamp release to hemostasis at the suture line (time frame: During surgical procedure). The study lists 2 primary outcomes in all. 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 15 Dec 2017.