search
Back to results

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

Primary Purpose

Mastectomy; Lymphedema

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ablation
Sponsored by
SurgiQuest, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mastectomy; Lymphedema focused on measuring comparison of ablation devices

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Baylor St. Luke's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HelixAR Electrosurgical Generator (HEG)

Conventional Electrosurgical Coagulation (CEC) Systems

Arm Description

Argon gas and high frequency electrical current ablation device

Standard Bovie electrosugical device without argon gas

Outcomes

Primary Outcome Measures

The time measured from post-mastectomy to hemostasis for each operated breast.
time

Secondary Outcome Measures

drain output
ml

Full Information

First Posted
November 13, 2019
Last Updated
July 8, 2021
Sponsor
SurgiQuest, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04165525
Brief Title
ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology Study
Acronym
CHEST
Official Title
ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology (CHEST) Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SurgiQuest, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastectomy; Lymphedema
Keywords
comparison of ablation devices

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Perspective, randomized, concurrently controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HelixAR Electrosurgical Generator (HEG)
Arm Type
Active Comparator
Arm Description
Argon gas and high frequency electrical current ablation device
Arm Title
Conventional Electrosurgical Coagulation (CEC) Systems
Arm Type
Active Comparator
Arm Description
Standard Bovie electrosugical device without argon gas
Intervention Type
Device
Intervention Name(s)
Ablation
Intervention Description
comparison of using an argon gas and high frequency electrical current ablation device with a standard Bovie electrosugical device without argon gas.
Primary Outcome Measure Information:
Title
The time measured from post-mastectomy to hemostasis for each operated breast.
Description
time
Time Frame
Inter-operative
Secondary Outcome Measure Information:
Title
drain output
Description
ml
Time Frame
up to two weeks post surgery
Other Pre-specified Outcome Measures:
Title
infection rate
Description
comparison between arms
Time Frame
two months from procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
cynthia C Harris, BS
Phone
8326776747
Email
cindy@clinregconsult.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michael A Daniel, BS, MS,MB
Phone
4154070223
Email
madaniel@clinregconsult.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey A Carter, MD
Organizational Affiliation
Baylor St. Luke's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor St. Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Menegaz
Email
Brian.Menegaz@bcm.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
26010605
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.
Results Reference
background
Citation
Steiner, C.A.; Weiss, A.J.; Barrett, M.L.; Fingar, K.R.; Davis, P.H (2016).
Results Reference
background
Links:
URL
https://seer.cancer.gov/statfacts/html/breast.html
Description
Breast cancer statstical facts

Learn more about this trial

ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology Study

We'll reach out to this number within 24 hrs