ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology Study

Not Applicable

• Conditions: Mastectomy; Lymphedema
• Interventions: Device: Ablation

• Registration Number: NCT04165525
• Lead Sponsor: SurgiQuest, Inc.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-18
• Status Verified: 2021-05
• Study Start: 2021-05-26
• Last Update Submitted: 2021-07-08
• Last Update Posted: 2021-07-09
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HelixAR Electrosurgical Generator (HEG)	Ablation	Argon gas and high frequency electrical current ablation device
Conventional Electrosurgical Coagulation (CEC) Systems	Ablation	Standard Bovie electrosugical device without argon gas

Primary Outcome Measures

Name	Time	Method
The time measured from post-mastectomy to hemostasis for each operated breast.	Inter-operative	time

Secondary Outcome Measures

Name	Time	Method
drain output	up to two weeks post surgery	ml

Trial Locations

Locations (1)

Baylor St. Luke's Medical Center; 🇺🇸 Houston, Texas, United States