ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology Study

Study Overview
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Brief Summary
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A PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE DEVICE EFFICACY BETWEEN THE HELIXAR ELECTROSURGICAL GENERATOR (HEG) VS. CONVENTIONAL ELECTROSURGICAL COAGULATION (CEC) FOR CUTTING AND/OR COAGULATION OF TISSUE DURING MASTECTOMY PROCEDURES

Detailed Description
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The objective of this study is to evaluate device efficacy between the HelixAR Electrosurgical Generator (HEG) and Conventional Electrosurgical Coagulation (CEC) Systems for cutting and/or coagulation of tissue during mastectomy procedures and reconstructive surgery. The study is designed and powered to demonstrate the superiority of the HEG to CEC in relation to a key efficacy measure: post-mastectomy procedure time to hemostasis. Secondary outcome measures include: infection, drain duration, total drain output, blood loss, and device related adverse events. These outcomes will be evaluated in a controlled population undergoing mastectomy procedures.

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

Conditions
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Mastectomy; Lymphedema

Intervention / Treatment
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* Device: Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 80 years of age; Capable and willing to give informed consent; 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: Advanced refusal of blood transfusion, if necessary; Active systemic or cutaneous infection or inflammation; Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids; Uncontrolled diabetes mellitus 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); Severe co-existing morbidities having a life expectancy of less than 30 days; Currently involved in any other investigational clinical studies that could influence outcomes; Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%; Renal insufficiency (serum creatinine of > 2.5 mg/dl); Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating; Patients who have had previous partial mastectomies with scar tissue affecting the area to be resected.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Perspective, randomized, concurrently controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HelixAR Electrosurgical Generator (HEG)<br>Argon gas and high frequency electrical current ablation device | Device: Ablation<br>* comparison of using an argon gas and high frequency electrical current ablation device with a standard Bovie electrosugical device without argon gas.<br>|
| Active Comparator: Conventional Electrosurgical Coagulation (CEC) Systems<br>Standard Bovie electrosugical device without argon gas | Device: Ablation<br>* comparison of using an argon gas and high frequency electrical current ablation device with a standard Bovie electrosugical device without argon gas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time measured from post-mastectomy to hemostasis for each operated breast. | time | Inter-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| drain output | ml | up to two weeks post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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comparison of ablation devices