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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03160170
Other study ID # 20161061
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 20, 2017
Est. completion date December 28, 2018

Study information

Verified date April 2019
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

- Rate of clogging of suction device.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date December 28, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Jackson Memorial Hospital Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami Ludwig Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Estimated Blood Loss Amount of blood loss from incision time to screw placement 1.5 hours
Secondary Time of Exposure Length of operation in minutes 1.5 hours
Secondary Rate of Clogging Average number of times the suction tip of the device had to be unclogged 1.5 hours
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