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Completed

NCT Number: NCT02341430

A Longitudinal Prospective Outcomes Study of Laparoscopic Abdominal Wall Hernia Repair Using Symbotex™ Composite Mesh

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.

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Key information

Conditions

Grade I Ventral Hernia Grade II Ventral Hernia Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

About this study

This study is being done to validate the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias. It will also set the groundwork for a future clinical trial in which the efficacy of Symbotex® can be compared to other synthetic mesh products on the market.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • Use of more than one of the same study mesh is not an exclusion criterion in and of itself, so long as the type of mesh is selected according to the randomization protocol. In other words, if the hernia defect is larger than the largest Symbotex™ mesh available, two or more Symbotex mesh pieces may be used to appropriately repair the hernia defect.

Treatment and study plan

Symbotex™ Composite Mesh

Device

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

Primary outcomes

  1. Hernia Recurrence

    Time frame: One year

  2. Quality of Life

    Time frame: One year

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

    Time frame: One year

  4. Reoperation Rate

    Time frame: One year

  5. Percutaneous Intervention Rate

    Time frame: One year

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

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Anne Arundel Health System Research Institute

Other

Collaborators

  • Medtronic - MITG

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 19, 2015
Registry last updated
Feb 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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