Recruiting

Harmonic Scalpel

Sponsor:

Sentara Cardiovascular Research Institute

Code:

NCT00591552

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Harmonic ACE23P Scalpel

Electrocautery

Study Details

Brief summary:

In an effort to elucidate whether the Harmonic Scalpel will improve sealing lymphatics and decrease lymphatic drainage thereby decreasing the length of time that chest tubes are required and minimizing length of stay; the Harmonic Scalpel will be compared to a control group which uses electrocautery. This study will assess these two different methods to determine if there is a notable decrease in the amount of drainage with one versus the other.

Conditions

Lung Cancer

Study ID

NCT00591552

Start date

Dec, 2007

Status verified date

Nov, 2023

Completion date

Nov, 2024

Anticipated

Primary completion date

Nov, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing resection for stage 1, 2 or 3A lung cancer.
  • Patients between the ages of 20-75.

Exclusion Criteria:

  • History of Congestive Heart Failure.
  • History of renal failure, ie., creatinine greater than 2.2.
  • Patients with bulky or matted lymph nodes in stage 3A.
  • Current pregnancy.
  • Current participation in another study involving an investigational device or drug.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group A

Electrocautery used for dissection.

active comparator: Group B

Harmonic Scalpel used for dissection

Interventions

Harmonic ACE23P Scalpel

Lymph node dissection

Electrocautery

Primary outcome measure

  • Amount of chest tube drainage [ Time Frame: daily ]

Central Contacts and Locations

Central contacts

Laura Pine, RN, BSN

757-388-2732ljpine@sentara.com

Michelle Collier, RN, BSN

757-388-7511mlcollie@sentara.com

Locations

Sentara Norfolk General Hospital/Sentara Heart Hospital

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Laura Pine, RN, BSN

757-388-2732ljpine@sentara.com

Michelle Collier, RN, BSN

757-388-7511mlcollie@sentara.com

More Information

Sponsor

Sentara Cardiovascular Research Institute

Last update posted

Nov 21, 2023

Last verified

Nov, 2023

Keywords

  • Lung cancer
  • Lymph node dissection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sentara Cardiovascular Research Institute on 2023-11-21.