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Efficacy of Suction Enabled Retraction Device | Clinical Trials | Clareo Health

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TERMINATEDNANCT03160170

Efficacy of Suction Enabled Retraction Device

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 ...

Lead sponsor: University of Miami•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Miami

Collaborators

Ludwig Medical Corporation

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.

Age

22 - 99 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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

Exclusion Criteria

•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)
•Operative cases where a single surgeon performs both sides of exposure
•Pregnant women
•Prisoners
•Adults unable to consent

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 15, 2019Terms

Trial snapshot

StatusTERMINATED

PhaseNA

Enrollment20

Start dateJun 2017

Last updatedMay 15, 2019

Condition

Surgical Blood Loss Spinal Surgery

Locations shown

Jackson Memorial Hospital

Miami, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 15, 2019Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions