Freedom Inguinal Hernia Repair System Study | NCT01984996

Studies
Freedom Inguinal Hernia Repair System Study

NCT01984996

Sponsor

Insightra Medical, Inc.

Status

Terminated

Last Update Posted

Jun 9, 2016Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Primary Inguinal Hernia

Interventions

Freedom ProFlor Inguinal Hernia Implant

Countries

United States
Austria
Italy

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

Jan 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company was dissolved.

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Dec 2017Estimated

Completion Date

Not provided

First Submitted Date

Nov 4, 2013

First Submission Date that Met QC Criteria

Nov 7, 2013

First Posted Date

Nov 15, 2013Estimated

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

Jun 7, 2016

Last Update Posted Date

Jun 9, 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 primary objective of this study is to evaluate patient quality-of-life (QOL) after inguinal hernia repair. "Carolinas Comfort Scale" (CCS) assessments will be held at regular intervals.

The secondary objective of the study is to follow short-term and long-term study-related complications/adverse events.

Detailed Description

Not provided

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

100Estimated

Label	Type	Description	Intervention Names
Freedom ProFlor Inguinal Hernia Implant	Experimental		Device: Freedom ProFlor Inguinal Hernia Implant

Name	Type	Description	Arm Group Labels	Other Names
Freedom ProFlor Inguinal Hernia Implant	Device		Freedom ProFlor Inguinal Hernia Implant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure changes from baseline in Carolina Comfort Scale (CCS) scores at specified time intervals	Measure quality of life for patients undergoing inguinal hernia repair.	1 week, 3, 6, 9, 12, 18, 24, and 36 months.

Secondary Outcomes

Measure	Description	Time Frame
Evaluate the 14-day pain and medication log	Patient will record pain score and medications for 14 consecutive days.	14 days

Other Outcomes

Measure	Description	Time Frame
Study-related complications/adverse events		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Scheduled to undergo routine inguinal hernia repair
Competent to give consent
Clinically relevant inguinal hernia (classification: NYHUS I, II, IIIa)
Defect size at operation is between 5mm and 35mm
Diagnosed with unilateral, direct, indirect or mixed inguinal hernia
Primary hernia at the operative site
Male or female
Life expectancy of at least 12 months
At least 18 years of age

Exclusion Criteria:

Signs of obvious local or systemic infection
Any previous surgery on the hernia operative site
Hernia is not in the inguinal area
Hernia is not identified as indirect or direct
Femoral hernias
Known collagen disorder
Presenting with unstable angina or NYHA class of IV
Known Pregnancy
Active drug user
Recurrence of a repair by any method
Patients with giant inguinoscrotal hernia or abdominal wall defect >35 mm in diameter - e.g. large direct or combined inguinal hernia type Nyhus IIIb / EHS P L/M 1/2/3
Immunosuppression, prednisone>15 mg/day, active chemotherapy
End stage renal disease
Abdominal ascites
Skin infection in area of surgical field
BMI >35
Peritoneum cannot be closed

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karl LeBlanc, M.D., M.B.A., F.A.C.S.	Our Lady of the Lake Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Metabolic Clinic and Research Center		Los Angeles	California	90033	United States
Witham Health Services