CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 142 enrolled
Drug / intervention
articulating Enseal +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02163538
NCT02163538N/ACompleted
CompareCT.gov

A Comparison of Industry Leading Energy Devices for Use in Gynecologic Laparoscopy: Articulating Enseal Versus Ligasure Energy Devices

University of Louisville·interventional·Posted Jun 13, 2014·Updated Feb 13, 2018

In Brief

A clinical study evaluating articulating Enseal and Ligasure device for Task Performance. Completed, enrolled 142 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTask Performance
CountriesUnited States
CollaboratorsEthicon Endo-Surgery

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 13, 2014
Enrollment StartJul 1, 2014
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.1 years ago

Interventions

articulating Ensealdevice

Vessel-sealing device used for laparoscopic hysterectomy.

Ligasure devicedevice

Vessel-sealing device used for laparoscopic hysterectomy.