PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy

NCT00960154 | Terminated Results

• 1 other identifier: PEAK VP-00078
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this clinical study is to quantify the difference in thermal injury depth at the surgical margin in breast lumpectomy specimens excised with the PlasmaBlade; to subjectively assess histopathologic sample quality metrics; to examine the role that electrosurgical artifact may play in revision lumpectomy procedures; and to compare these endpoints to the standard of care (SOC) technology.

Conditions

Breast Cancer

Keywords

Lumpectomy; PlasmaBlade; Electrosurgery; PEAK Surgical; Medtronic Advanced Energy; Medtronic

Outcome Measures

Primary Outcomes (1)

• Histological Metrics: Amount of Overlying Adherent Char on Slide; Damage to Tumor Epithelium; Effect of Electrosurgical Damage on Diagnostic Quality of Lumpectomy Specimen

  Overall histological quality score will be a composite of the histological metrics

  Intraoperative

Secondary Outcomes (1)

• Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring

  Intraoperatively and 1-2 weeks postoperatively

Study Arms (2)

PlasmaBlade

EXPERIMENTAL

The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.

Device: PEAK PlasmaBlade

SOC

ACTIVE COMPARATOR

The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.

Procedure: Traditional Electrosurgery with scalpel

Interventions

PEAK PlasmaBlade DEVICE

The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade including the skin incision

Also known as: PlasmaBlade

PlasmaBlade

Traditional Electrosurgery with scalpel PROCEDURE

The skin incision will be performed using a standard scalpel; the subcutaneous dissection will be performed with traditional electrosurgery using the Cut and Coagulation modes.

Also known as: Scalpel, Electrosurgery, SOC

SOC

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 90 years old
• Physically healthy, stable weight
• Requiring lumpectomy with wire localization for suspected or confirmed malignant breast disease.
• Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
• Subject must be willing and able to comply with all follow-up evaluations

You may not qualify if:

• Age younger than 18 or greater than 90 years old
• Infection (local or systemic)
• Cognitive impairment or mental illness
• Severe cardiopulmonary deficiencies
• Unable to follow instructions or complete follow-up
• Currently taking any medication known to affect healing
• Currently enrolled in another investigational device or drug trial

Sponsors & Collaborators

• Medtronic Surgical Technologies: lead

Study Sites (2)

El Camino Surgery Center

Mountain View, California, 94040, United States

Location

Palo Alto Medical Foundation

Mountain View, California, 94040, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Hyperthermia

Interventions

Laser Therapy; Electrosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Limitations and Caveats

Upon Medtronic's acquisition of PEAK surgical, a study integrity audit was undertaken. Results of the audit showed that patient's rights and safety were maintained, but the source data, including baseline demographics, were unverifiable.

Results Point of Contact

• Title: Robert Swain, PhD
• Organization: Medtronic Surgical Technologies

robert.e.swain@medtronic.com

(+1-603) 294-5428

Study Officials

• Peter Naruns, MD

  Midpeninsula Surgical Associates

  PRINCIPAL INVESTIGATOR

• Khoi Tran, MD

  Palo Alto Medical Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 17, 2009
• Study Start: July 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: January 8, 2013
• Results First Posted: January 3, 2013

Record last verified: 2013-01

Locations

US (2)