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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 ]

Measure Type Primary
Measure Title Raw Task Load Index (TLX) Score Assigned by Surgeons
Measure Description

The Official NASA Task Load Index (TLX) is a subjective workload assessment tool to allow users to perform subjective workload assessments on operator(s) working with various human-machine interface systems. By incorporating a multi-dimensional rating procedure, NASA TLX derives an overall workload score based on a weighted average of ratings on six subscales given below. The overall workload score ranges between 0 and 100 with 100 being the most demanding.

Mental Demand Physical Demand Temporal Demand Performance Effort Frustration

Time Frame 18 months  

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.


Measured Values
   Articulating Enseal   Ligasure Device 
Participants Analyzed   70   70 
Raw Task Load Index (TLX) Score Assigned by Surgeons 
[Units: Units on a scale]
Median (Inter-Quartile Range)
 51.7 
 (39.6 to 59.0) 
 32.5 
 (17.7 to 48.1) 


Statistical Analysis 1 for Raw Task Load Index (TLX) Score Assigned by Surgeons
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Wilcoxon (Mann-Whitney)
P Value [4] 0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

Measure Type Secondary
Measure Title Intra- and Post-operative Complications
Measure Description No text entered.
Time Frame 18 months  

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.


Measured Values
   Articulating Enseal   Ligasure Device 
Participants Analyzed   70   70 
Intra- and Post-operative Complications 
[Units: Participants]
Count of Participants
 1   2 


Statistical Analysis 1 for Intra- and Post-operative Complications
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Chi-squared
P Value [4] 1.00
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

Measure Type Secondary
Measure Title Estimated Blood Loss
Measure Description No text entered.
Time Frame 18 months  

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.


Measured Values
   Articulating Enseal   Ligasure Device 
Participants Analyzed   70   70 
Estimated Blood Loss 
[Units: mL]
Median (Inter-Quartile Range)
 100 
 (50 to 200) 
 100 
 (50 to 150) 


Statistical Analysis 1 for Estimated Blood Loss
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Chi-squared
P Value [4] 0.582
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

Measure Type Secondary
Measure Title Need for Second Energy Device Intra-operatively
Measure Description No text entered.
Time Frame 18 months  

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.


Measured Values
   Articulating Enseal   Ligasure Device 
Participants Analyzed   70   70 
Need for Second Energy Device Intra-operatively 
[Units: Participants]
Count of Participants
 10   0 


Statistical Analysis 1 for Need for Second Energy Device Intra-operatively
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Chi-squared
P Value [4] 0.0031
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

Measure Type Secondary
Measure Title Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis.
Measure Description No text entered.
Time Frame During procedure  

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.


Measured Values
   Articulating Enseal   Ligasure Device 
Participants Analyzed   70   70 
Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis. 
[Units: Minutes]
Median (Inter-Quartile Range)
 35 
 (25 to 48) 
 30 
 (22 to 41) 


Statistical Analysis 1 for Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis.
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Wilcoxon (Mann-Whitney)
P Value [4] 0.0281
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

Measure Type Secondary
Measure Title Time Required to Complete Procedure
Measure Description No text entered.
Time Frame End of surgery up to 4 hours  

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.


Measured Values
   Articulating Enseal   Ligasure Device 
Participants Analyzed   70   70 
Time Required to Complete Procedure 
[Units: Minutes]
Median (Inter-Quartile Range)
 97 
 (80 to 129) 
 85 
 (69 to 120) 


Statistical Analysis 1 for Time Required to Complete Procedure
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Wilcoxon (Mann-Whitney)
P Value [4] .0821
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  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
No text entered.


  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