ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology Study (CHEST)

This is an interventional treatment trial for Mastectomy; Lymphedema focused on measuring comparison of ablation devices Read More

Inclusion Criteria:

1. 18 to 80 years of age;
2. Capable and willing to give informed consent;
3. Acceptable candidate for a unilateral or bilateral mastectomy and reconstruction. All subjects enrolled and consented will undergo mastectomy with a breast reconstruction procedure, if it is in the subject's best interest.

Exclusion Criteria:

1. Advanced refusal of blood transfusion, if necessary;
2. Active systemic or cutaneous infection or inflammation;
3. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
4. Uncontrolled diabetes mellitus
5. Known, significant history of bleeding diathesis, or coagulopathy, or Von Willebrand's disease or current platelet count < 100,000 cells/mm3, or baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
6. Severe co-existing morbidities having a life expectancy of less than 30 days;
7. Currently involved in any other investigational clinical studies that could influence outcomes;
8. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
9. Renal insufficiency (serum creatinine of > 2.5 mg/dl);
10. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
11. Patients who have had previous partial mastectomies with scar tissue affecting the area to be resected.