Effectiveness and Safety of Gordian Surgical's TroClose1200™ | NCT02746653

Studies
Effectiveness and Safety of Gordian Surgical's TroClose1200™

NCT02746653

Sponsor

Gordian Surgical

Status

Unknown status

Last Update Posted

Apr 21, 2016Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Hernia

Interventions

TroClose1200(TM)

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Aug 2016Estimated

Completion Date

Aug 2018Estimated

First Submitted Date

Apr 12, 2016

First Submission Date that Met QC Criteria

Apr 20, 2016

First Posted Date

Apr 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2016

Last Update Posted Date

Apr 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Use of TroClose1200(TM) for access port and closure device	Experimental	TroClose in 1 port	Device: TroClose1200(TM)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hagar Mizrahi, Dr.	Contact	+972 52 3469739		hagarmizrahi@gmail.com

Overall Officials

Name	Affiliation	Role
Hagar Mizrahi, Dr.	Poryia Medical Center, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Poryia Medical Center	Recruiting	Teberias			Israel

Condition Browse Module

MeSH Terms

ID	Term
D006547	Hernia

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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