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ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology Study

NCT04165525 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2021-07-09

No results posted yet for this study

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

Conditions

  • Mastectomy; Lymphedema

Interventions

DEVICE

Ablation

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

Sponsors & Collaborators

  • SurgiQuest, Inc.

    lead INDUSTRY

Principal Investigators

  • Stacey A Carter, MD · Baylor St. Luke's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2022-06-30
Completion
2022-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04165525 on ClinicalTrials.gov