ATLAS

Clinical Trial Title A Prospective Trial of a Bio-absorbable Mesh in Challenging Laparoscopic Ventral or Incisional Hernia Repair (ATLAS)
Trial Status Closed to Enrollment
Start Date 09/01/2016
Location legacy-good-samaritan-medical-center
Trial Type Surgery - General
Specific Condition Hernia Repair
Description The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ ST in subjects receiving laparoscopic ventral or incisional hernia repair at high risk for surgical site occurrence (SSO). Subjects at high risk are defined as having 1 or more of the following co-morbid conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.
Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  • Subject must be 18 years of age or older
  • Subject must be willing to give written informed consent
  • Subject must be diagnosed with ventral or abdominal incisional hernia
  • Subject must be willing to undergo laparoscopic hernia repair using intraabdominal placement (with or without Component Separation Technique (CST))
  • Surgeon must be able to fully close the hernia defect. Defect closure is defined as complete reapproximation of fascial edges, leaving no gap. Since the safety and effectiveness of Phasix™ ST Mesh in bridging repairs has not been evaluated or established, the defect should be closed prior to mesh use.
  • Subject is expected to meet the criteria for a Class I wound

  • Subjects must have 1 or more of the following pre-study conditions:

    1. Body Mass Index (BMI) between 30-40 kg/m2, inclusive
    2. Active smoker (including if attempts to quit smoking within two weeks of surgery have failed and the patient is still an active smoker at the time of surgery)
    3. COPD presence on patient self-report
    4. Diabetes mellitus (if yes, diagnosis to be confirmed via medical records or laboratory results according to 2014 Joslin Clinical Guideline for Adults with Diabetes)(Appendix 5)
    5. Immunosuppression
    6. Coronary Artery Disease
    7. Chronic corticosteroid use: greater than 6 months systemic use
    8. Serum albumin less than 3.4 g/dL
    9. Advanced age: 75 years or older
IRB Number 10686
Notes

https://clinicaltrials.gov/ct2/show/NCT02712398

Enrollment status is:
Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
Principal Investigator Daniel Tseng, MD
Contact Name Sheryl Ames
Contact Phone 503-413-8324
Contact Fax 503-413-6861
Contact E-Mail sames@lhs.org