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Electrosurgical Generator

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

N/A
Waitlist Available
Led By Stacey A Carter, MD
Research Sponsored by SurgiQuest, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two months from procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial compares a new surgical device, the HelixAR Electrosurgical Generator, with traditional methods for cutting tissue and stopping bleeding during mastectomy surgeries. It aims to see if the new device can reduce surgery time and improve outcomes like less blood loss and fewer infections. The HelixAR Electrosurgical Generator is part of a lineage of electrosurgical devices that have been evolving since the introduction of the first electric scalpel by Harvey Cushing in 1926.

Eligible Conditions
  • Mastectomy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two months from procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and two months from procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The time measured from post-mastectomy to hemostasis for each operated breast.
Secondary study objectives
drain output
Other study objectives
infection rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Conventional Electrosurgical Coagulation (CEC) SystemsActive Control1 Intervention
Standard Bovie electrosugical device without argon gas
Group II: HelixAR Electrosurgical Generator (HEG)Active Control1 Intervention
Argon gas and high frequency electrical current ablation device

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Who is running the clinical trial?

SurgiQuest, Inc.Lead Sponsor
5 Previous Clinical Trials
590 Total Patients Enrolled
Stacey A Carter, MDPrincipal InvestigatorBaylor St. Luke's Medical Center
~18 spots leftby Dec 2025
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