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Thermal Spread Into the Interstitial Portion of the Fallopian Tubes Using the Ligasure Device at Time of Hysterectomy

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.
ClinicalTrials.gov Identifier: NCT00746018
Recruitment Status : Completed
First Posted : September 3, 2008
Results First Posted : January 30, 2018
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cervical Cancer
Ovarian Cancer
Uterine Cancer
Intervention: Device: LigaSure vessel sealing system

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Total Hysterectomy The patients will already be undergoing a total hysterectomy with removal of the tubes and ovaries for a specific indication diagnosed or defined by their surgeon. If the patient is suitable to proceed by the surgeon, then he/she will perform a right salpingooophorectomy with the LigaSure devices.

Participant Flow:   Overall Study
    Total Hysterectomy
STARTED   39 
COMPLETED   39 
NOT COMPLETED   0 



  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
Total Hysterectomy The patients will already be undergoing a total hysterectomy with removal of the tubes and ovaries for a specific indication diagnosed or defined by their surgeon. If the patient is suitable to proceed by the surgeon, then he/she will perform a right salpingooophorectomy with the LigaSure devices.

Baseline Measures
   Total Hysterectomy 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Years]
Median (Full Range)
 56 
 (35 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      39 100.0% 
Male      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   2.6% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      7  17.9% 
White      31  79.5% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   39 


  Outcome Measures

1.  Primary:   To Determine if the LigaSure Device, Which we Routinely Used for Removal of Tubes and Ovaries, is Effective at Destroying All Tubal Cells Comprising the Fallopian Tube Including Those Cells Within the Cornua of the Uterus.   [ Time Frame: conclusion of the study ]


  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: Nadeem Abu-Rustum, M.D.
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-7051
e-mail: abu-rusn@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00746018     History of Changes
Other Study ID Numbers: 08-092
First Submitted: September 2, 2008
First Posted: September 3, 2008
Results First Submitted: January 4, 2018
Results First Posted: January 30, 2018
Last Update Posted: April 11, 2018