NCT04165525

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 26, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

July 9, 2021

Status Verified

May 1, 2021

Enrollment Period

1.1 years

First QC Date

November 13, 2019

Last Update Submit

July 8, 2021

Conditions

Mastectomy; Lymphedema

Keywords

comparison of ablation devices

Outcome Measures

Primary Outcomes (1)

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

    time

    Inter-operative

Secondary Outcomes (1)

  • drain output

    up to two weeks post surgery

Other Outcomes (1)

  • infection rate

    two months from procedure

Study Arms (2)

HelixAR Electrosurgical Generator (HEG)

ACTIVE COMPARATOR

Argon gas and high frequency electrical current ablation device

Device: Ablation

Conventional Electrosurgical Coagulation (CEC) Systems

ACTIVE COMPARATOR

Standard Bovie electrosugical device without argon gas

Device: Ablation

Interventions

AblationDEVICE

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

Conventional Electrosurgical Coagulation (CEC) SystemsHelixAR Electrosurgical Generator (HEG)

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

RECRUITING

Related 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.

    PMID: 26010605BACKGROUND

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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Stacey A Carter, MD

    Baylor St. Luke's Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

cynthia C Harris, BS

CONTACT

8326776747cindy@clinregconsult.com

Michael A Daniel, BS, MS,MB

CONTACT

4154070223madaniel@clinregconsult.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Perspective, randomized, concurrently controlled
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 18, 2019

Study Start

May 26, 2021

Primary Completion

June 30, 2022

Study Completion

December 30, 2022

Last Updated

July 9, 2021

Record last verified: 2021-05

Locations

US(1)