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PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy

NCT01193556 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2013-01-03

Study results available
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Summary

The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade® TnA during subcapsular tonsillectomy; to monitor and record post-operative clinical outcome variables; and to compare these endpoints to the Standard of Care (SOC).

Conditions

  • Tonsillitis

Interventions

DEVICE

PEAK PlasmaBlade TnA

The PEAK PlasmaBlade will be used for the tonsillectomy.

DEVICE

Traditional Electrosurgery with scalpel

Traditional electrosurgery for the tonsillectomy.

Sponsors & Collaborators

  • Medtronic Surgical Technologies

    lead INDUSTRY

Principal Investigators

  • Brian Weeks, MD · Senta Clinic

  • Mark Spitzer, DO · Mark Spitzer, DO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-03-31
Completion
2012-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01193556 on ClinicalTrials.gov