Effectiveness and Safety of Gordian Surgical's TroClose1200™

Gordian Surgical50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hernia

Interventions

TroClose1200(TM)DEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Poryia Medical Center

Teberias, Israel

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

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

Central Contacts

Hagar Mizrahi, Dr.

CONTACT

+972 52 3469739 hagarmizrahi@gmail.com

Data from ClinicalTrials.gov

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