NCT02341430

Brief Summary

This study is being done to test the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

January 8, 2015

Last Update Submit

February 6, 2019

Conditions

Grade I Ventral HerniaGrade II Ventral Hernia

Keywords

herniasynthetic mesh

Outcome Measures

Primary Outcomes (6)

  • Hernia Recurrence

    One year

  • Quality of Life

    One year

  • Hernia associated pain and movement limitations pre-surgery compared to post-surgery

    One year

  • Reoperation Rate

    One year

  • Percutaneous Intervention Rate

    One year

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability"

    One year

Interventions

Symbotex™ Composite MeshDEVICE

Repair of a Grade I or II ventral hernia according to VHWG classification system with Symbotex™ Composite Mesh

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Grade I or II ventral hernia according to VHWG classification system
  • Pre-operative informed consent is obtainable

You may not qualify if:

  • Not candidate for laparoscopic approach for repair of their hernia
  • Determination in the operating room that biologic mesh is needed over permanent mesh
  • Fascial defect less than 3 cm in greatest dimension
  • Concurrent placement of another mesh (synthetic or biologic ) at the site where the study mesh is placed
  • Grade III or IV ventral hernia according to VHWG system
  • ASA score IV or above
  • Any disease or condition along with the surgeon's clinical judgment that contraindicates the use of study mesh. These include but are not limited to the presence of chronically infected tissues subjecting patient to risk of synthetic mesh infection, accidental bowel injury during surgery or anatomy of the patient that is not receptive to laparoscopic surgery or mesh implantation.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

Related Publications (6)

  • Ventral Hernia Working Group; Breuing K, Butler CE, Ferzoco S, Franz M, Hultman CS, Kilbridge JF, Rosen M, Silverman RP, Vargo D. Incisional ventral hernias: review of the literature and recommendations regarding the grading and technique of repair. Surgery. 2010 Sep;148(3):544-58. doi: 10.1016/j.surg.2010.01.008. Epub 2010 Mar 20.

    PMID: 20304452BACKGROUND

  • Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years' experience with 850 consecutive hernias. Ann Surg. 2003 Sep;238(3):391-9; discussion 399-400. doi: 10.1097/01.sla.0000086662.49499.ab.

    PMID: 14501505BACKGROUND

  • SymbotexTM clinging effect observed during the design validation conducted by Covidien in porcine model in May 2013- covidien internal memorandum 0901CR261a (July 2013)

    BACKGROUND

  • Malangoni MA and Rosen MJ. Chapter 46: Hernias, Sabiston Textbook of Surgery 19th Edition. Elsevier; Philadelphia, PA. 2012: 1128-1135

    BACKGROUND

  • Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg. 2008 Apr;206(4):638-44. doi: 10.1016/j.jamcollsurg.2007.11.025. Epub 2008 Feb 1.

    PMID: 18387468BACKGROUND

  • Itani KM, Hur K, Kim LT, Anthony T, Berger DH, Reda D, Neumayer L; Veterans Affairs Ventral Incisional Hernia Investigators. Comparison of laparoscopic and open repair with mesh for the treatment of ventral incisional hernia: a randomized trial. Arch Surg. 2010 Apr;145(4):322-8; discussion 328. doi: 10.1001/archsurg.2010.18.

    PMID: 20404280BACKGROUND

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Adrian Park, M.D.

    Anne Arundel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 19, 2015

Study Start

January 1, 2016

Primary Completion

September 11, 2017

Study Completion

December 31, 2018

Last Updated

February 7, 2019

Record last verified: 2019-02

Locations

US(1)