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Effectiveness and Safety of Gordian Surgical's TroClose1200™

NCT02746653 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-04-21

No results posted yet for this study

Summary

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.

Conditions

  • Hernia

Interventions

DEVICE

TroClose1200(TM)

Creation of access port and closure it by the same device, TroClose1200(TM)

Sponsors & Collaborators

  • Gordian Surgical

    lead INDUSTRY

Principal Investigators

  • Hagar Mizrahi, Dr. · Poryia Medical Center, Israel

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-08-31
Completion
2018-08-31

Countries

  • Israel

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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 NCT02746653 on ClinicalTrials.gov