Effectiveness and Safety of Gordian Surgical's TroClose1200™

NCT02746653 | Unknown

• 1 other identifier: GOR-CLN-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia

Keywords

Fascia Closure Device, hernia,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Secondary efficacy outcome assessed by hernia signs at 6,12,and 24 months

  Up to 2 years

• Secondary Safety Outcome assessed by surgical complications

  up to 6 weeks

Study Arms (1)

Use of TroClose1200(TM) for access port and closure device

EXPERIMENTAL

TroClose in 1 port

Device: TroClose1200(TM)

Interventions

TroClose1200(TM) DEVICE

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

Use of TroClose1200(TM) for access port and closure device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gordian Surgical: lead

Study Sites (1)

Poryia Medical Center

Teberias, Israel

RECRUITING

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Hagar Mizrahi, Dr.

  Poryia Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hagar Mizrahi, Dr.

CONTACT

+972 52 3469739; hagarmizrahi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 21, 2016
• Study Start: April 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2018
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

IL (1)