ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology Study

Mastectomy; Lymphedema Clinical Trial

— CHEST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04165525
• Other study ID #: DD01112019
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2021
• Source: SurgiQuest, Inc.
• Contact: cynthia C Harris, BS
• Phone: 8326776747
• Email: cindy[@]clinregconsult.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphedema
• Mastectomy; Lymphedema

Intervention

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

Locations

Country	Name	City	State
United States	Baylor St. Luke's Medical Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
SurgiQuest, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View Citation

Steiner, C.A.; Weiss, A.J.; Barrett, M.L.; Fingar, K.R.; Davis, P.H (2016).

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	infection rate	comparison between arms	two months from procedure
Primary	The time measured from post-mastectomy to hemostasis for each operated breast.	time	Inter-operative
Secondary	drain output	ml	up to two weeks post surgery

External Links

•   Breast cancer statstical facts