Advertisement

Topics

PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy

2014-07-23 21:13:37 | BioPortfolio

Summary

The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during lumpectomy; to monitor and record thermal injury depth at the surgical margin and need for additional tissue excision; and to compare these endpoints to the current standard of care.

Description

Lumpectomy is a surgical procedure performed to remove a localized mass of breast tissue that is suspicious for malignancy. The purpose of lumpectomy is to minimize the amount of tissue removed from the breast to retain normal breast architecture while simultaneously removing all of the suspected cancerous tissue. Typically, a scalpel is used for the skin incision and a traditional electrosurgical device is used to cut away any cancerous tissue.

The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy and a highly-insulated handpiece design to enable precision cutting and coagulation at the point of application. The PlasmaBlade has received FDA clearance for use in plastic, general, and ENT surgery, and has demonstrated a significantly reduced thermal injury profile in incised tissue compared to traditional electrosurgical devices. It is hypothesized that this benefit may improve the pathological analysis of excised breast lumps.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Lumpectomy

Intervention

PEAK PlasmaBlade, Traditional Electrosurgery with scalpel

Location

El Camino Surgery Center
Mountain View
California
United States
94040

Status

Enrolling by invitation

Source

Peak Surgical, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:37-0400

Clinical Trials [412 Associated Clinical Trials listed on BioPortfolio]

PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty

The objective of this clinical study is to evaluate healing of incisions made with the PEAK PlasmaBlade 4.0 compared to scalpel and traditional electrosurgery (Bovie); to monitor and recor...

PEAK PlasmaBlade™ 4.0 vs. Traditional Electrosurgery in Mastectomy

The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during mastectomy; to monitor and record post-operative pain, drain output, and sk...

PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adve...

Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery

Low thermal dissection devices have been introduced as a tool to improve surgical outcomes. PlasmaBlade, a low thermal dissection device, has shown to be associated with effective cutting,...

Low Thermal Electrosurgical Device for Atraumatic Internal Thoracic Artery Harvesting

Electrosurgery is fundamental to the precise, fast and bloodless preparation of internal thoracic artery grafts in cardiac surgery. The PEAK PlasmaBlade is a monopolar electrosurgical devi...

PubMed Articles [4610 Associated PubMed Articles listed on BioPortfolio]

Comparison of Electrosurgical Devices for Cervical Conization: Novel Monopolar Scalpel (VIO) Versus Ultrasonic Scalpel.

The aim of this study was to compare the outcomes associated with the use of a novel monopolar scalpel with those associated with the use of an ultrasonic scalpel for cervical conization of cervical i...

Evaluation of a novel cricothyroidotomy introducer in a simulated obese porcine model: a randomised crossover comparison with scalpel cricothyroidotomy.

The Difficult Airway Society 2015 guidelines for management of unanticipated difficulties in tracheal intubation in adults have generated much discussion regarding Plan D: emergency front-of-neck acce...

Effectiveness of harmonic scalpel in patients submitted to total thyroidectomy: systematic review with meta-analysis.

The objective of this study was to evaluate the efficacy and safety of the harmonic scalpel compared to the conventional technique in patients submitted to total thyroidectomy.

Transanal repair of rectocele with high frequency radio scalpel.

This is a prospective randomized study to analyze results obtained in two groups of patients, affected by stage 2 rectocele and treated with rectum anterior wall repair and strength, performed with st...

Effectiveness of harmonic scalpel in laparoscopic treatment of simple renal cyst.

We retrospectively evaluated the results of Harmonic Scalpel (Ethicon, Cincinnati, Ohio) used for laparoscopic decortication of simple renal cysts (SRC). Between May 2011 and December 2014, 28 patient...

Medical and Biotech [MESH] Definitions

Procedures using an electrically heated wire or scalpel to treat hemorrhage (e.g., bleeding ulcers) and to ablate tumors, mucosal lesions, and refractory arrhythmias. It is different from ELECTROSURGERY which is used more for cutting tissue than destroying and in which the patient is part of the electric circuit.

Division of tissues by a high-frequency current applied locally with a metal instrument or needle. (Stedman, 25th ed)

A plant genus of the family AMARANTHACEAE, order Caryophyllales, which has been used in traditional medicine (MEDICINE, CHINESE TRADITIONAL).

A system of traditional medicine which is based on the beliefs and practices of the Chinese culture.

A system of traditional medicine which is based on the beliefs and practices of the Tibetan culture.

More From BioPortfolio on "PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Breast Cancer
Track and monitor developments in breast cancer research and commercial development.  Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...


Searches Linking to this Trial