Blood LossPhase 4NCT01331499
Salient Aquamantys Spine Trial
A Phase 4 study testing Bipolar Sealer (Aquamantys) in people with Blood Loss, run by Salient Surgical Technologies at 3 sites in United States.
Trial summary
The purpose of this study is to compare standard of care hemostasis techniques with and without the use of Aquamantys in reducing peri-operative blood loss. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Blood Loss
- What is being tested?
- Bipolar Sealer (Aquamantys)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2011to Apr 2013
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be candidate for three level (or greater) fusion surgery from T1 to S1 utilizing a direct posterior approach
- Male or female 18 to 70 years of age (inclusive)
- Must sign the IRB approved Informed Consent Form
Who cannot join
- Undergoing spinal fusion for < 3 lumbar levels, or using an approach other than direct posterior
- Undergoing an interbody fusion
- Planned use of hypotensive anaesthesia
- Pregnant or lactating
- Morbid obesity, defined as Body Mass Index (BMI) greater than 40
- Previously diagnosed coagulopathy or bleeding diasthesis
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- Currently, or within the previous 7 days prior to surgery, taking any medications that would produce bleeding diathesis including, but not limited to NSAIDs, aspirin, clopidogrel (Plavix), ticlopidine, or valproic acid
- History of significant cardiac disorders that would necessitate special fluid management protocols
- Serious trauma other than that confined to the spine
- History of acute myocardial infarction and/or acute angina within the past year prior to enrollment
- PT/INR >1.3 in the 14 days prior to surgery
- PTT > 40 in the 14 days prior to surgery
- Platelet count <100K in the 14 days prior to surgery
- Based on clinical history, physical exam and subject presentation, subject has or is suspected to have a history of alcohol and/or drug abuse that would preclude subject from providing adequate consent and/or complying with study requirements
- Prisoner or transient
- Enrolled in another drug or device investigational study (currently or within past 30 days)
- Unable or unwilling to sign the Informed Consent Form or comply with protocol specified procedures
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rush University Medical Center
Chicago, Illinois, 60612
William Beaumont Hospital
Royal Oak, Michigan, 48073
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
About this study
Official title: A Post-Market, Prospective, Multicenter, Randomized Trial Comparing the Use of Standard of Care Blood Sparing Techniques With and Without the Aquamantys System to Facilitate Hemostasis in Subjects Undergoing Multi-level Spinal Fusions
The purpose of this study is to compare standard of care hemostasis techniques with and without the use of Aquamantys in reducing peri-operative blood loss.
Read the detailed description
The primary objective of the study is to assess the effectiveness of Aquamantys in reducing peri-operative blood loss compared with standard electrocautery
Secondary objectives include :
- Rate and volume of transfusions
- Evaluating the reduction in hemoglobin and hematocrit values post- operatively
- LOS costs, and operative time
- Gathering operator feedback on qualitative criteria, including ease of use and surgical visualization between the two treatment groups
- Conditions
- Blood Loss
- Being tested
- Bipolar Sealer (Aquamantys), Standard of Care
- Keywords
- Blood loss, transfusions, instrumented spinal fusion
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar Sealer (Aquamantys)Device
Also called Aquamantys
Standard of care blood sparing techniques along with the use of bipolar sealer
Standard of CareProcedure or surgery
Standard of care blood sparing techniques without the useof bipolar sealer
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Sealer | Experimental | Standard of care blood sparing techniques with bipolar sealer Receives: Device: Bipolar Sealer (Aquamantys) |
| Control | Active comparator | Standard of care blood sparing techniques without the use of bipolar sealer Receives: Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actual Peri-operative Blood Loss
Actual blood loss (ABL) will be calculated using a study specified formula using laboratory data from up to 72 hours post-surgery. ABL will be compared between treatment groups
Measured: Up to 72 hours post-operatively
Secondary outcomes (3)
Frequency and volume of transfusions
The frequency and volume of transfusions will be measured between treatment groups
Measured: Up to 72 hours post-operatively
Reduction in hemoglobin and hematocrit values post-operatively
The reduction in hemoglobin and hematocrit values will be evaluated between the two treatment groups
Measured: Upto 72 hours post-operatively
Length of stay costs and operativ time
Total length of staycosts and operative time will be compared between treatment groups.
Measured: Up to 21 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2012 (estimated)
- Study completionApr 2013 (estimated)
Why it stopped: Study terminated due to Medtronic acquisition
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood LossStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salient Surgical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Fischgrund, M.D., Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331499
- Sponsor's protocol ID
- SAL-SP-10-001
- Status last verified
- Jun 2012
- First submitted
- 6 Apr 2011
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market, Prospective, Multicenter, Randomized Trial Comparing the Use of Standard of Care Blood Sparing Techniques With and Without the Aquamantys System to Facilitate Hemostasis in Subjects Undergoing Multi-level Spinal Fusions
- ClinicalTrials.gov ID
- NCT01331499
- Acronym / sponsor ID
- SAL-SP-10-001
- Conditions
- Blood Loss
- Keywords
- Blood loss, transfusions, instrumented spinal fusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to Medtronic acquisition
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Salient Surgical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 8 Apr 2011 (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 compare standard of care hemostasis techniques with and without the use of Aquamantys in reducing peri-operative blood loss.
Detailed description
The primary objective of the study is to assess the effectiveness of Aquamantys in reducing peri-operative blood loss compared with standard electrocautery
Secondary objectives include :
- Rate and volume of transfusions
- Evaluating the reduction in hemoglobin and hematocrit values post- operatively
- LOS costs, and operative time
- Gathering operator feedback on qualitative criteria, including ease of use and surgical visualization between the two treatment groups
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar Sealer | Experimental | Device: Bipolar Sealer (Aquamantys)Standard of care blood sparing techniques with bipolar sealer |
| Control | Active comparator | Procedure: Standard of CareStandard of care blood sparing techniques without the use of bipolar sealer |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be candidate for three level (or greater) fusion surgery from T1 to S1 utilizing a direct posterior approach
- Male or female 18 to 70 years of age (inclusive)
- Must sign the IRB approved Informed Consent Form
Key exclusion criteria (17 listed)
- Undergoing spinal fusion for < 3 lumbar levels, or using an approach other than direct posterior
- Undergoing an interbody fusion
- Planned use of hypotensive anaesthesia
- Pregnant or lactating
- Morbid obesity, defined as Body Mass Index (BMI) greater than 40
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 |
|---|---|---|
| Bipolar Sealer (Aquamantys)Also: AquamantysStandard of care blood sparing techniques along with the use of bipolar sealer | Device | Bipolar Sealer |
| Standard of CareStandard of care blood sparing techniques without the useof bipolar sealer | Procedure or surgery | Control |
Primary outcome
Actual Peri-operative Blood Loss
Time frame: Up to 72 hours post-operatively
Actual blood loss (ABL) will be calculated using a study specified formula using laboratory data from up to 72 hours post-surgery. ABL will be compared between treatment groups
3 secondary outcomes
Frequency and volume of transfusions
Time frame: Up to 72 hours post-operatively
Reduction in hemoglobin and hematocrit values post-operatively
Time frame: Upto 72 hours post-operatively
Length of stay costs and operativ time
Time frame: Up to 21 days post-operatively
Results and safety
The study was stopped early (reason given: Study terminated due to Medtronic acquisition). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
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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.
Jeffrey Fischgrund, M.D. principal investigator
Corewell Health East
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bipolar Sealer (Aquamantys) in people with Blood Loss, run by Salient Surgical Technologies at 3 sites in United States.
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 17 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: stopped early, as of the sponsor's last update on 7 Jun 2012. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Study terminated due to Medtronic acquisition). Results are not available in the source record.
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?
Actual Peri-operative Blood Loss (time frame: Up to 72 hours post-operatively). 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 Jun 2012.