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Articulating Enseal Versus Ligasure Energy Devices

NCT02163538 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2018-02-13

Study results available
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Summary

This is an exploratory study to assess the ability of the raw-TLX (raw Task Load Index) ergonomic assessment tool to detect differences in surgeon workload when using commercially available advanced bipolar devices. It is anticipated that the raw-TLX version of the validated NASA-TLX ergonomic assessment tool will detect less surgeon effort required in the procedure when articulating ENSEAL is utilized. The Articulating ENSEAL device may also positively impact other variables such as blood loss, operative time and cost.

Conditions

  • Task Performance

Interventions

DEVICE

articulating Enseal

Vessel-sealing device used for laparoscopic hysterectomy.

DEVICE

Ligasure device

Vessel-sealing device used for laparoscopic hysterectomy.

Sponsors & Collaborators

  • Ethicon Endo-Surgery

    collaborator INDUSTRY

  • University of Louisville

    lead OTHER

Principal Investigators

  • Resad Pasic, MD, PhD · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-04-30
Completion
2016-04-30

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 NCT02163538 on ClinicalTrials.gov