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Efficacy of Suction Enabled Retraction Device

NCT03160170 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-05-15

Study results available
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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

Interventions

DEVICE

SISTER device

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

Sponsors & Collaborators

  • Ludwig Medical Corporation

    collaborator UNKNOWN

  • University of Miami

    lead OTHER

Principal Investigators

  • Ian Cõté, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-20
Primary Completion
2018-10-31
Completion
2018-12-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03160170 on ClinicalTrials.gov