Articulating Enseal Versus Ligasure Energy Devices

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02163538
Recruitment Status : Completed
First Posted : June 13, 2014
Results First Posted : January 17, 2018
Last Update Posted : February 13, 2018
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Resad Pasic, University of Louisville

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Other
Condition: Task Performance
Interventions: Device: articulating Enseal
Device: Ligasure device

  Participant Flow

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Articulating Enseal

This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.

articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.

Ligasure Device

This group of women undergoing hysterectomy is randomized to the Ligasure energy device.

Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.

Total Total of all reporting groups

Baseline Measures
   Articulating Enseal   Ligasure Device   Total 
Overall Participants Analyzed 
[Units: Participants]
 70   70   140 
[Units: Years]
Mean (Standard Deviation)
 41.6  (6.9)   41.3  (7.7)   41.4  (7.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      70 100.0%      70 100.0%      140 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
United States   70   70   140 

  Outcome Measures

1.  Primary:   Raw Task Load Index (TLX) Score Assigned by Surgeons   [ Time Frame: 18 months ]

2.  Secondary:   Intra- and Post-operative Complications   [ Time Frame: 18 months ]

3.  Secondary:   Estimated Blood Loss   [ Time Frame: 18 months ]

4.  Secondary:   Need for Second Energy Device Intra-operatively   [ Time Frame: 18 months ]

5.  Secondary:   Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis.   [ Time Frame: During procedure ]

6.  Secondary:   Time Required to Complete Procedure   [ Time Frame: End of surgery up to 4 hours ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Resad Pasic
Organization: University Louisville
phone: 502-561-7465

Responsible Party: Resad Pasic, University of Louisville Identifier: NCT02163538     History of Changes
Other Study ID Numbers: Energy Devices-UL
First Submitted: June 11, 2014
First Posted: June 13, 2014
Results First Submitted: April 25, 2017
Results First Posted: January 17, 2018
Last Update Posted: February 13, 2018