ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology Study

Last updated: July 8, 2021
Sponsor: SurgiQuest, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphedema

Treatment

N/A

Clinical Study ID

NCT04165525
DD01112019
  • Ages 18-80
  • Female

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

Eligibility Criteria

Inclusion

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. Allsubjects enrolled and consented will undergo mastectomy with a breast reconstructionprocedure, if it is in the subject's best interest.

Exclusion

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'sdisease or current platelet count < 100,000 cells/mm3, or baseline INR ≥1.8, orfibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24hours);
  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 influenceoutcomes;
  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 theprocedure, or lactating;
  11. Patients who have had previous partial mastectomies with scar tissue affecting thearea to be resected.

Study Design

Total Participants: 82
Study Start date:
May 26, 2021
Estimated Completion Date:
December 30, 2022

Study 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.

Connect with a study center

  • Baylor St. Luke's Medical Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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