Clinical trial NCT02746653: Effectiveness and Safety of Gordian Surgical's TroClose1200™
Official title: Effectiveness and Safety of Gordian Surgical's TroClose1200™, a Trocar With built-in Closure Device Capability, in Subjects Undergoing Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia
Keywords: Fascia Closure Device, hernia,
Lead sponsor: Gordian Surgical
Sponsor class: INDUSTRY
First posted: 2016-04-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Subject is ≥ 18 years old and less than 65 years.
2. Subject is a candidate for laparoscopic surgery with at least one 12 mm trocar is to be used apart from the endoscopic access port.
3. Subject is capable and willing to comply with, and be present at, the follow-up clinic visits of the 6 weeks visit.
4. Subject is able and willing to sign a written informed consent form.

Exclusion Criteria:

1. Patients presenting factors that affect the scarring process, such as malnutrition (serum proteins \<5 g/dl or Albumin below 3 g/dl).
2. Advanced cancer.
3. Perioperative hemodynamic instability

Primary outcomes:
measure: Primary Outcome is the proportion of successfully created ports and their closure by the TRoClosed
timeFrame: Perioperative
Secondary outcomes:
measure: Secondary efficacy outcome assessed by hernia signs at 6,12,and 24 months
timeFrame: Up to 2 years
measure: Secondary Safety Outcome assessed by surgical complications
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Teberias
country: Israel
facility: Poryia Medical Center
Study officials:
affiliation: Poryia Medical Center, Israel
name: Hagar Mizrahi, Dr.
role: PRINCIPAL_INVESTIGATOR
References: