Non-emergent, Soft Tissue Procedures, Performed Via an Open ApproachNCT01719172
A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue
A study testing Veriset™ Hemostatic Patch in people with Non-emergent, Soft Tissue Procedures, Performed Via an Open Approach, run by Medtronic - MITG at 3 sites in 2 countries.
Trial summary
The objective of this study is to determine the safety of Veriset™ Hemostatic Patch when used during non-emergent, open, soft tissue surgery where a topical hemostatic agent would be used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-emergent, Soft Tissue Procedures, Performed Via an Open Approach
- What is being tested?
- Veriset™ Hemostatic Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject or authorized representative has provided informed consent.
- Subject is ≥ 18 years old.
- Subject is scheduled for nonemergent surgery where a topical hemostatic agent would be used to control bleeding emanating from a tissue bed following organ dissection or removal or a bleeding tumor tissue bed following resection or dissection, via an open approach.
- Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
- Subject has an appropriate Target Bleeding Site (TBS) during the surgical procedure.
- TBS bleeding assessment is Type 2 or 3 (refer to table in protocol).
Who cannot join
- Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding.
- Subject has an estimated life expectancy of less than 6 months.
- Subject is scheduled for another planned surgery and the subsequent surgery would jeopardize the previous application of study treatment.
- Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death.
- Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with the study.
- Subject has an active local infection at the TBS.
- The investigator determines that participation in the study may jeopardize teh safety or welfare of the subject.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
The objective of this study is to determine the safety of Veriset™ Hemostatic Patch when used during non-emergent, open, soft tissue surgery where a topical hemostatic agent would be used.
- Being tested
- Veriset™ Hemostatic Patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veriset™ Hemostatic PatchDevice
Topical Hemostat
| Study group | Role | What they receive |
|---|---|---|
| Veriset™ Hemostatic Patch | Experimental | Topical hemostat Receives: Device: Veriset™ Hemostatic Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment
Success will be defined as hemostasis obtained within 5 minutes. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Measured: Intra-operative (Day 0)
Secondary outcomes (2)
Proportion of Subjects Who Achieve Hemostasis Within 1 Minute
Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Measured: Intra-operative (Day 0)
Median Time to Achieve Hemostasis
Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Measured: Intra-operative (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-emergent, Soft Tissue Procedures, Performed Via an Open ApproachStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719172
- Sponsor's protocol ID
- COVEUST0278
- Status last verified
- Jan 2014
- First submitted
- 30 Oct 2012
- Last updated
- 27 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue
- ClinicalTrials.gov ID
- NCT01719172
- Acronym / sponsor ID
- COVEUST0278
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Posted 27 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the safety of Veriset™ Hemostatic Patch when used during non-emergent, open, soft tissue surgery where a topical hemostatic agent would be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Veriset™ Hemostatic Patch | Experimental | Device: Veriset™ Hemostatic PatchTopical hemostat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject or authorized representative has provided informed consent.
- Subject is ≥ 18 years old.
- Subject is scheduled for nonemergent surgery where a topical hemostatic agent would be used to control bleeding emanating from a tissue bed following organ dissection or removal or a bleeding tumor tissue bed following resection or dissection, via an open approach.
- Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
- Subject has an appropriate Target Bleeding Site (TBS) during the surgical procedure.
Key exclusion criteria (7 listed)
- Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding.
- Subject has an estimated life expectancy of less than 6 months.
- Subject is scheduled for another planned surgery and the subsequent surgery would jeopardize the previous application of study treatment.
- Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death.
- Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with the 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 |
|---|---|---|
| Veriset™ Hemostatic PatchTopical Hemostat | Device | Veriset™ Hemostatic Patch |
Primary outcome
Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment
Time frame: Intra-operative (Day 0)
Success will be defined as hemostasis obtained within 5 minutes. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
2 secondary outcomes
Proportion of Subjects Who Achieve Hemostasis Within 1 Minute
Time frame: Intra-operative (Day 0)
Median Time to Achieve Hemostasis
Time frame: Intra-operative (Day 0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veriset™ Hemostatic Patch in people with Non-emergent, Soft Tissue Procedures, Performed Via an Open Approach, run by Medtronic - MITG at 3 sites in 2 countries.
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 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 27 Feb 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 Germany, Austria. 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?
Yes. Results are posted in the registry (first posted 27 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment (time frame: Intra-operative (Day 0)). 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 27 Feb 2014.