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

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

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

Study Overview

• Status: Recruiting
• Conditions: Mastectomy; Lymphedema
• Intervention / Treatment: Device: Ablation

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 Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: cynthia C Harris, BS; Phone Number: 8326776747; Email: cindy@clinregconsult.com
• Study Contact Backup: Name: Michael A Daniel, BS, MS,MB; Phone Number: 4154070223; Email: madaniel@clinregconsult.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor St. Luke's Medical Center
      • Contact: Brian Menegaz; Email: Brian.Menegaz@bcm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
infection rate	comparison between arms	two months from procedure

Collaborators and Investigators

• Sponsor: SurgiQuest, Inc.
• Investigators: Principal Investigator: Stacey A Carter, MD, Baylor St. Luke's Medical Center

Publications and helpful links

General Publications

• McGuire A, Brown JA, Malone C, McLaughlin R, Kerin MJ. Effects of age on the detection and management of breast cancer. Cancers (Basel). 2015 May 22;7(2):908-29. doi: 10.3390/cancers7020815.
• Steiner, C.A.; Weiss, A.J.; Barrett, M.L.; Fingar, K.R.; Davis, P.H (2016).

Helpful Links

• Breast cancer statstical facts

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: comparison of ablation devices
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: DD01112019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes