Mastectomy; LymphedemaCHESTNCT04165525
ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology Study
A study testing Ablation in people with Mastectomy; Lymphedema, run by SurgiQuest, Inc. at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Mastectomy; Lymphedema
- What is being tested?
- Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Baylor St. Luke's Medical Center
Houston, Texas, 77030
Brian Menegaz, Brian.Menegaz@bcm.edu
About this study
Official title: ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology (CHEST) Study
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
Read the 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.
- Conditions
- Mastectomy; Lymphedema
- Being tested
- Ablation
- Keywords
- comparison of ablation devices
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationDevice
comparison of using an argon gas and high frequency electrical current ablation device with a standard Bovie electrosugical device without argon gas.
| Study group | Role | What they receive |
|---|---|---|
| HelixAR Electrosurgical Generator (HEG) | Active comparator | Argon gas and high frequency electrical current ablation device Receives: Device: Ablation |
| Conventional Electrosurgical Coagulation (CEC) Systems | Active comparator | Standard Bovie electrosugical device without argon gas Receives: Device: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time measured from post-mastectomy to hemostasis for each operated breast.
time
Measured: Inter-operative
Secondary outcomes (1)
drain output
ml
Measured: up to two weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start26 May 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mastectomy; LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Perspective, randomized, concurrently controlled
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SurgiQuest, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stacey A Carter, MD, Principal investigator, Baylor St. Luke's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165525
- Sponsor's protocol ID
- DD01112019
- Acronym
- CHEST
- Status last verified
- May 2021
- First submitted
- 13 Nov 2019
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 26010605Steiner, C.A.; Weiss, A.J.; Barrett, M.L.; Fingar, K.R.; Davis, P.H (2016).
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology (CHEST) Study
- ClinicalTrials.gov ID
- NCT04165525
- Acronym / sponsor ID
- CHEST / DD01112019
- Conditions
- Mastectomy; Lymphedema
- Keywords
- comparison of ablation devices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- SurgiQuest, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Perspective, randomized, concurrently controlled
| Arm | Type | Receives |
|---|---|---|
| HelixAR Electrosurgical Generator (HEG) | Active comparator | Device: AblationArgon gas and high frequency electrical current ablation device |
| Conventional Electrosurgical Coagulation (CEC) Systems | Active comparator | Device: AblationStandard Bovie electrosugical device without argon gas |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablationcomparison of using an argon gas and high frequency electrical current ablation device with a standard Bovie electrosugical device without argon gas. | Device | Conventional Electrosurgical Coagulation (CEC) Systems, HelixAR Electrosurgical Generator (HEG) |
Primary outcome
The time measured from post-mastectomy to hemostasis for each operated breast.
Time frame: Inter-operative
time
1 secondary outcome
drain output
Time frame: up to two weeks post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Background: PubMed 26010605McGuire 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.
- BackgroundSteiner, C.A.; Weiss, A.J.; Barrett, M.L.; Fingar, K.R.; Davis, P.H (2016).
- Breast cancer statstical factsLink provided by the sponsor.
Related trials for Mastectomy; Lymphedema
Recruiting
Effect of Resisted Deep Breathing and Myofascial Release in Postmastectomy
Post Mastectomy Lymphedema
Enrolling by invitation
Ultrasound-Guided Percutaneous Cryoneurolysis to Treat Postoperative Pain After Mastectomy
Mastectomy; Lymphedema
RecruitingPhase 2
IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases
Breast Cancer, Axillary Nodal Disease
Recruiting
Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Breast Cancer Surgery
Paravertebral Block, Pectoral Nerve Block
Recruiting
Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy
Mastectomy; Lymphedema, Chronic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey A Carter, MD principal investigator
Baylor St. Luke's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation in people with Mastectomy; Lymphedema, run by SurgiQuest, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact cynthia C Harris, BS (8326776747, cindy@clinregconsult.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time measured from post-mastectomy to hemostasis for each operated breast. (time frame: Inter-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04165525, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021; AzTrials last refreshed its copy on 1 Nov 2026.