Surgical Blood LossNCT03160170
Efficacy of Suction Enabled Retraction Device
A study testing SISTER device in people with Surgical Blood Loss and Spinal Surgery, run by University of Miami at 1 site in United States.
Trial summary
This is a prospective randomized controlled trial of the Suction-Integrated Surgical Tissue Elevator \& Retractor [SISTER] device to assess: Effects on operative time and efficiency of exposure in open lumbar spine cases. Effect on total blood loss during the exposure part of the operation. Read more about this study
- Who is it for?
- Ages 22 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Blood Loss, Spinal Surgery
- What is being tested?
- SISTER device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2017to 28 Dec 2018
- 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 22 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking
- Patients undergoing lumbar one to sacral one open instrumentation
- Surgery performed by the Departments of Neurological Surgery and Orthopedics at the University of MIami Miller School of Medicine
Who cannot join
- Less than 22 years old
- Procedure does not involve instrumentation
- Prior lumbar spine surgery involving more than one level
- BMI less than 20 or greater than 35
- Known bleeding conditions ( ex. Factor V Leiden, Von Willebrand)
- Routinely taking anticoagulation medicine (ex. aspirin 325 mg/day, Plavix)
Show all 10Show fewer
- Operative cases where a single surgeon performs both sides of exposure
- Pregnant women
- Prisoners
- Adults unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Efficacy of Suction Enabled Retraction Device in Lumbar Spine Surgery
This is a prospective randomized controlled trial of the Suction-Integrated Surgical Tissue
Elevator \& Retractor [SISTER] device to assess:
- Effects on operative time and efficiency of exposure in open lumbar spine cases.
- Effect on total blood loss during the exposure part of the operation.
- Rate of clogging of suction device.
Read the detailed description
The device, Suction-Integrated Surgical Tissue Elevator \& Retractor [SISTER], is shaped like a Cobb elevator but also has a hollow core allowing suction tubing to be connected. Thus, a single hand can be used to retract and suction at the same time while the other hand separates soft tissue from the bones with electrocautery. This set up which is proposed to be more efficient will be evaluated in this study.
- Conditions
- Surgical Blood Loss, Spinal Surgery
- Being tested
- SISTER device
- Keywords
- open lumbar spine surgery, operative time and efficiency, Suction-Integrated Surgical Tissue Elevator and Retractor
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SISTER deviceDevice
Also called Cobb
Use of the Suction-Integrated Surgical Tissue Elevator \& Retractor (SISTER) device during surgery
| Study group | Role | What they receive |
|---|---|---|
| Use of Cobb device | Experimental | Use of SISTER device during surgery Receives: Device: SISTER device |
| Control | No intervention | Standard exposure technique and instruments will be used during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Blood Loss
Amount of blood loss from incision time to screw placement
Measured: 1.5 hours
Secondary outcomes (2)
Time of Exposure
Length of operation in minutes
Measured: 1.5 hours
Rate of Clogging
Average number of times the suction tip of the device had to be unclogged
Measured: 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start20 Jun 2017
- Primary completion31 Oct 2018
- Study completion28 Dec 2018
Why it stopped: Resources no longer available
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 Surgical 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig Medical Corporation
- Responsible party
- Principal investigator, Ian Cote, University of Miami
- Investigators
- Ian Cõté, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160170
- Sponsor's protocol ID
- 20161061
- Status last verified
- Apr 2019
- First submitted
- 15 May 2017
- Last updated
- 15 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data (IPD)
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Efficacy of Suction Enabled Retraction Device in Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT03160170
- Acronym / sponsor ID
- 20161061
- Conditions
- Surgical Blood Loss, Spinal Surgery
- Keywords
- open lumbar spine surgery, operative time and efficiency, Suction-Integrated Surgical Tissue Elevator and Retractor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Resources no longer available
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Ludwig Medical Corporation
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Posted 15 May 2019
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 randomized controlled trial of the Suction-Integrated Surgical Tissue
Elevator \& Retractor [SISTER] device to assess:
- Effects on operative time and efficiency of exposure in open lumbar spine cases.
- Effect on total blood loss during the exposure part of the operation.
- Rate of clogging of suction device.
Detailed description
The device, Suction-Integrated Surgical Tissue Elevator \& Retractor [SISTER], is shaped like a Cobb elevator but also has a hollow core allowing suction tubing to be connected. Thus, a single hand can be used to retract and suction at the same time while the other hand separates soft tissue from the bones with electrocautery. This set up which is proposed to be more efficient will be evaluated in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of Cobb device | Experimental | Device: SISTER deviceUse of SISTER device during surgery |
| Control | No intervention | –Standard exposure technique and instruments will be used during surgery |
Who may qualify
- Ages
- 22 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking
- Patients undergoing lumbar one to sacral one open instrumentation
- Surgery performed by the Departments of Neurological Surgery and Orthopedics at the University of MIami Miller School of Medicine
Key exclusion criteria (10 listed)
- Less than 22 years old
- Procedure does not involve instrumentation
- Prior lumbar spine surgery involving more than one level
- BMI less than 20 or greater than 35
- Known bleeding conditions ( ex. Factor V Leiden, Von Willebrand)
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 |
|---|---|---|
| SISTER deviceAlso: CobbUse of the Suction-Integrated Surgical Tissue Elevator \& Retractor (SISTER) device during surgery | Device | Use of Cobb device |
Primary outcome
Estimated Blood Loss
Time frame: 1.5 hours
Amount of blood loss from incision time to screw placement
2 secondary outcomes
Time of Exposure
Time frame: 1.5 hours
Rate of Clogging
Time frame: 1.5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD)
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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.
Ian Cõté, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SISTER device in people with Surgical Blood Loss and Spinal Surgery, run by University of Miami at 1 site 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 10 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 15 May 2019. 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2019). 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?
Estimated Blood Loss (time frame: 1.5 hours). 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 May 2019; AzTrials last refreshed its copy on 28 Oct 2026.