NCT04165525

ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology Study

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: SurgiQuest, Inc. · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mastectomy; Lymphedema

Interventions

Type	Name	Description
DEVICE	Ablation	comparison of using an argon gas and high frequency electrical current ablation device with a standard Bovie electrosugical device without argon gas.

Timeline

• Start date: 2021-05-26
• Primary completion: 2022-06-30
• Completion: 2022-12-30
• First posted: 2019-11-18
• Last updated: 2021-07-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study