ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology Study

Status unconfirmed · Not applicable

Conditions studied: Mastectomy; Lymphedema

In brief

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

Key facts

Study ID

NCT04165525

Run by

SurgiQuest, Inc.

People needed

82

Starts

2021-05-26

Expected to finish

2022-12-30

Last updated by the study team

2021-07-09

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 18 to 80 years of age;
• Capable and willing to give informed consent;
• 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.

You may not qualify if…

• Advanced refusal of blood transfusion, if necessary;
• Active systemic or cutaneous infection or inflammation;
• Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
• Uncontrolled diabetes mellitus
• 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);
• Severe co-existing morbidities having a life expectancy of less than 30 days;
• Currently involved in any other investigational clinical studies that could influence outcomes;
• Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
• Renal insufficiency (serum creatinine of > 2.5 mg/dl);
• Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
• Patients who have had previous partial mastectomies with scar tissue affecting the area to be resected.

Where it is running

• Baylor St. Luke's Medical Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.