An interventional study of TroClose1200(TM) in Hernia, sponsored by Gordian Surgical. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-04-21.
Sponsored by Gordian Surgical · Not applicable, Interventional, and Treatment
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.
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.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 739 interventional studies indexed under Hernia.
Browse Hernia studies →Gordian Surgical is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
TroClose in 1 port
Device: TroClose1200(TM)
Creation of access port and closure it by the same device, TroClose1200(TM)
Primary Outcome is the proportion of successfully created ports and their closure by the TRoClosed
Operator will record trocar insertion, anchor deployment, ability to accommodate laparoscopic surgical tools within the cannula and closure ability of the port for each of the ports created by the TroClose
Time frame: Perioperative
Secondary efficacy outcome assessed by hernia signs at 6,12,and 24 months
Hernia signs assessment by palpation by the surgeon at 6 weeks. Hernia signs assessment by palpation by the surgeon and by US at 12 months. Hernia signs assessment by palpation by the surgeon and by US at 24 months.
Time frame: Up to 2 years
Secondary Safety Outcome assessed by surgical complications
Surgical complication by Clavien Dindo classification perioperatively and at 6 weeks
Time frame: up to 6 weeks
This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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