Effectiveness and Safety of Gordian Surgical's TroClose1200™ (GOR-CLN-01)

Effectiveness and Safety of Gordian Surgical's TroClose1200™, a Trocar With built-in Closure Device Capability, in Subjects Undergoing Laparoscopic Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Hernia
• Intervention / Treatment: Device: TroClose1200(TM)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hagar Mizrahi, Dr.; Phone Number: +972 52 3469739; Email: hagarmizrahi@gmail.com

Study Locations

• Israel
  • Teberias, Israel
    • Recruiting
    • Poryia Medical Center
    • Contact: Hagar Mizrahi, Dr.
    • Principal Investigator: Hagar Mizrahi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Use of TroClose1200(TM) for access port and closure device; TroClose in 1 port	Device: TroClose1200(TM); Creation of access port and closure it by the same device, TroClose1200(TM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 2 years
Secondary Safety Outcome assessed by surgical complications	Surgical complication by Clavien Dindo classification perioperatively and at 6 weeks	up to 6 weeks

Collaborators and Investigators

• Sponsor: Gordian Surgical
• Investigators: Principal Investigator: Hagar Mizrahi, Dr., Poryia Medical Center, Israel

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: April 20, 2016
• First Posted (Estimate): April 21, 2016

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 20, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Fascia Closure Device, hernia,
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: GOR-CLN-01