Efficacy of Suction Enabled Retraction Device

NCT03160170 | Terminated Results FDA Device

• 1 other identifier: 20161061
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Blood Loss; Spinal Surgery

Keywords

open lumbar spine surgery; operative time and efficiency; Suction-Integrated Surgical Tissue Elevator and Retractor

Outcome Measures

Primary Outcomes (1)

• Estimated Blood Loss

  Amount of blood loss from incision time to screw placement

  1.5 hours

Secondary Outcomes (2)

• Time of Exposure

  1.5 hours

• Rate of Clogging

  1.5 hours

Study Arms (2)

Use of Cobb device

EXPERIMENTAL

Use of SISTER device during surgery

Device: SISTER device

Control

NO INTERVENTION

Standard exposure technique and instruments will be used during surgery

Interventions

SISTER device DEVICE

Use of the Suction-Integrated Surgical Tissue Elevator \& Retractor (SISTER) device during surgery

Also known as: Cobb

Use of Cobb device

Eligibility Criteria

• Age: 22 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• Ludwig Medical Corporation: collaborator

Study Sites (1)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Results Point of Contact

• Title: Ian Cote
• Organization: University of Miami Miller School of Medicine

Icote@med.miami.edu

305-256-4492

Study Officials

• Ian Cõté, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 19, 2017
• Study Start: June 20, 2017
• Primary Completion: October 31, 2018
• Study Completion: December 28, 2018
• Last Updated: May 15, 2019
• Results First Posted: May 15, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)