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Articulating Enseal Versus Ligasure Energy Devices

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ClinicalTrials.gov Identifier: NCT02163538
Recruitment Status : Completed
First Posted : June 13, 2014
Results First Posted : January 17, 2018
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
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

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Articulating Enseal   Ligasure Device
STARTED   71   71 
COMPLETED   70   70 
NOT COMPLETED   1   1 
Protocol Violation                1                0 
Physician Decision                0                1 



  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.
No text entered.

Reporting Groups
  Description
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 
Age 
[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 ]
  Show Outcome Measure 1

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  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
e-mail: resad.pasic@louisville.edu



Responsible Party: Resad Pasic, University of Louisville
ClinicalTrials.gov 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