TerminatedNot Applicable

Efficacy of Suction Enabled Retraction Device

Stopped: Resources no longer available

United States20 participantsStarted 2017-06-20

Plain-language 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.

Who can participate

Age range

22 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Estimated Blood Loss

Timeframe: 1.5 hours

Trial details

NCT IDNCT03160170

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10-31

Results submitted2019-04-23

View on ClinicalTrials.gov More Surgical Blood Loss trials