Last updated on February 2018

Effectiveness and Safety of Gordian Surgical's TroClose1200


Brief description of study

The use of the TroClose1200 will be done in at least one 12mm planned access port per the TroClose1200 Instruction for Use. The procedure will be performed routinely. Adverse Events and device malfunctions, if any, will be recorded. Subjects will be hospitalized in accordance with the hospital guidance. All subjects will be followed at 2 weeks (+/- 4 days), at 6 weeks (+/- 1 week), at 12 months (+/- 1 month) and at 24 months (+/- 2 months) in which healing, signs of hernia and adverse events will be recorded. In the 12 and 24 months visit, the hernia signs will be evaluated by ultrasound.

Detailed Study Description

Subjects that sign the Informed Consent Form will be evaluated for eligible for the study per eligibility criteria. Subject medical background and underlying disease requiring intervention will be taken at screening. Procedure will be scheduled. Subjects that will eventually, for any reason, will not be operated with the TroClose1200, will be considered as "screen failures". The use of the TroClose1200 will be done in at least one 12mm planned access port per the TroClose1200 Instruction for Use. The procedure will be performed routinely. Duration of use of the TroClose1200 each time it is used will be measured, as well as the entire procedure duration, and the type of procedure. Adverse Events and device malfunctions, if any, will be recorded. The video seen in the monitors during the procedure will be kept as source data for any further analysis. The location of the TroClose1200 used, as well as the other trocars used location, will be drawn on a special chart. Subjects will be hospitalized in accordance with the hospital guidance. All subjects will be followed at 2 weeks (+/- 4 days), at 6 weeks (+/- 1 week), at 12 months (+/- 1 month) and at 24 months (+/- 2 months) in which healing, signs of hernia and adverse events will be recorded. In the 12 and 24 months visit, the hernia signs will be evaluated by ultrasound.

Clinical Study Identifier: NCT02746653

Contact Investigators or Research Sites near you

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Hagar Mizrahi

Poryia Medical Center
Teberias, Israel
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Recruitment Status: Open


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