Back to resultsEfficacy of Suction Enabled Retraction Device
Primary Purpose
Surgical Blood Loss, Spinal Surgery
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SISTER device
Sponsored by
About this trial
This is an interventional supportive care trial for Surgical Blood Loss focused on measuring open lumbar spine surgery, operative time and efficiency, Suction-Integrated Surgical Tissue Elevator and Retractor
Eligibility Criteria
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
Sites / Locations
- Jackson Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Use of Cobb device
Control
Arm Description
Use of SISTER device during surgery
Standard exposure technique and instruments will be used during surgery
Outcomes
Primary Outcome Measures
Estimated Blood Loss
Amount of blood loss from incision time to screw placement
Secondary Outcome Measures
Time of Exposure
Length of operation in minutes
Rate of Clogging
Average number of times the suction tip of the device had to be unclogged
Full Information
NCT ID
NCT03160170
First Posted
May 15, 2017
Last Updated
April 23, 2019
Sponsor
University of Miami
Collaborators
Ludwig Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03160170
Brief Title
Efficacy of Suction Enabled Retraction Device
Official Title
Intraoperative Efficacy of Suction Enabled Retraction Device in Lumbar Spine Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Resources no longer available
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
December 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Ludwig Medical Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Blood Loss, Spinal Surgery
Keywords
open lumbar spine surgery, operative time and efficiency, Suction-Integrated Surgical Tissue Elevator and Retractor
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Use of Cobb device
Arm Type
Experimental
Arm Description
Use of SISTER device during surgery
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard exposure technique and instruments will be used during surgery
Intervention Type
Device
Intervention Name(s)
SISTER device
Other Intervention Name(s)
Cobb
Intervention Description
Use of the Suction-Integrated Surgical Tissue Elevator & Retractor (SISTER) device during surgery
Primary Outcome Measure Information:
Title
Estimated Blood Loss
Description
Amount of blood loss from incision time to screw placement
Time Frame
1.5 hours
Secondary Outcome Measure Information:
Title
Time of Exposure
Description
Length of operation in minutes
Time Frame
1.5 hours
Title
Rate of Clogging
Description
Average number of times the suction tip of the device had to be unclogged
Time Frame
1.5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Cõté, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data (IPD)
Learn more about this trial
Efficacy of Suction Enabled Retraction Device
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