Clinical trial NCT04165525: ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology Study
Official title: ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology (CHEST) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mastectomy; Lymphedema
Keywords: comparison of ablation devices
Lead sponsor: SurgiQuest, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-18
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Perspective, randomized, concurrently controlled
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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. All subjects enrolled and consented will undergo mastectomy with a breast reconstruction procedure, if it is in the subject's best interest.

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'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);
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 influence outcomes;
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 the procedure, or lactating;
11. Patients who have had previous partial mastectomies with scar tissue affecting the area to be resected.

Primary outcomes:
measure: The time measured from post-mastectomy to hemostasis for each operated breast.
timeFrame: Inter-operative
Secondary outcomes:
measure: drain output
timeFrame: up to two weeks post surgery
Other outcomes:
measure: infection rate
timeFrame: two months from procedure
Locations:
city: Houston
country: United States
facility: Baylor St. Luke's Medical Center
state: Texas
Study officials:
affiliation: Baylor St. Luke's Medical Center
name: Stacey A Carter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGuire A, Brown JA, Malone C, McLaughlin R, Kerin MJ. Effects of age on the detection and management of breast cancer. Cancers (Basel). 2015 May 22;7(2):908-29. doi: 10.3390/cancers7020815.
citation: Steiner, C.A.; Weiss, A.J.; Barrett, M.L.; Fingar, K.R.; Davis, P.H (2016).