Effectiveness and Safety of Gordian Surgical's TroClose1200™

Hernia Clinical Trial

— GOR-CLN-01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02746653
• Other study ID #: GOR-CLN-01
• Status: Recruiting
• Phase: N/A
• First received: April 12, 2016
• Last updated: April 20, 2016
• Start date: April 2016
• Est. completion date: August 2018

Study information

• Verified date: April 2016
• Source: Gordian Surgical
• Contact: Hagar Mizrahi, Dr.
• Phone: +972 52 3469739
• Email: hagarmizrahi[@]gmail.com
• Is FDA regulated: No
• Health authority: Ministry of Health: Israel
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2018
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia

Intervention

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

Locations

Country	Name	City	State
Israel	Poryia Medical Center	Teberias

Sponsors (1)

Lead Sponsor	Collaborator
Gordian Surgical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Secondary Safety Outcome assessed by surgical complications	Surgical complication by Clavien Dindo classification perioperatively and at 6 weeks	up to 6 weeks	Yes