Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02341430
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : February 7, 2019
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Anne Arundel Health System Research Institute

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.

Condition or disease Intervention/treatment Phase
Grade I Ventral Hernia Grade II Ventral Hernia Device: Symbotex™ Composite Mesh Phase 4

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Longitudinal Prospective Outcomes Study of Laparoscopic Abdominal Wall Hernia Repair Using Symbotex™ Composite Mesh
Actual Study Start Date : January 2016
Actual Primary Completion Date : September 11, 2017
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia


Intervention Details:
  • Device: Symbotex™ Composite Mesh
    Repair of a Grade I or II ventral hernia according to VHWG classification system with Symbotex™ Composite Mesh


Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341430


Locations
Layout table for location information
United States, Maryland
Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Sponsors and Collaborators
Anne Arundel Health System Research Institute
Medtronic - MITG
Investigators
Layout table for investigator information
Principal Investigator: Adrian Park, M.D. Anne Arundel Medical Center

Publications:
Layout table for additonal information
Responsible Party: Anne Arundel Health System Research Institute
ClinicalTrials.gov Identifier: NCT02341430     History of Changes
Other Study ID Numbers: 689069
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Keywords provided by Anne Arundel Health System Research Institute:
hernia
synthetic mesh
Additional relevant MeSH terms:
Layout table for MeSH terms
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal