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Harmonic ACE®+7 Shears in Laparoscopic 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: NCT02278640
Recruitment Status : Completed
First Posted : October 30, 2014
Results First Posted : August 19, 2016
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery

Brief Summary:

This is a prospective, non-randomized, single arm, multicenter, study to assess the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing during total laparoscopic hysterectomy. The study will not modify or influence current surgeon technique. Investigators will perform each procedure using the device in compliance with their standard surgical approach and product labeling.

The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled, calibrated, and/or used in accordance with manufacturer design specifications, product instructions and guidelines


Condition or disease Intervention/treatment Phase
Benign Disease Where Total Hysterectomy is Indicated Device: Harmonic ACE®+7 Shears Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Multicenter, Study Evaluating Vessel Sealing Utilizing the Harmonic ACE®+7 Shears During Total Laparoscopic Hysterectomy
Study Start Date : October 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Harmonic ACE®+7 Shears
Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy
Device: Harmonic ACE®+7 Shears
Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature.




Primary Outcome Measures :
  1. Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Left Side. [ Time Frame: Intraoperative ]
    Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). "Yes" is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed.

  2. Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Right Side. [ Time Frame: Intraoperative ]
    Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). "Yes" is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed.


Secondary Outcome Measures :
  1. Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Left Side. [ Time Frame: Intraoperative ]
    Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). "Yes" is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed.

  2. Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Right Side. [ Time Frame: Intraoperative ]
    Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). "Yes" is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects satisfying all of the following criteria will be considered the screening population and will be eligible for participation in this study:

  1. Indicated for elective total laparoscopic hysterectomy
  2. Age >=40 years and no future desire for fertility

Exclusion Criteria:

Subjects with any of the following criteria will be excluded from the study:

Preoperative exclusion criteria:

  1. Known or suspected uncontrolled bleeding disorders
  2. Subjects unlikely to comply with protocol procedures or adhere to the study visit schedule
  3. Any condition rendering a subject unable to understand the nature, scope, and possible consequences of the study or study procedures
  4. Any Subject unwilling to sign the study informed consent document
  5. Any suspected malignancy
  6. Any Subject of childbearing potential with a positive or serum pregnancy test within 24 hours prior to surgery

    Intra-operative exclusion criteria:

  7. Any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278640


Locations
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United States, Florida
Florida Hospital Celebration Health
Celebration, Florida, United States, 34747
United States, Illinois
The Advanced Gynecological Surgery Institute
Schaumburg, Illinois, United States, 60173
Netherlands
Gynaecoloog (aandachtsgebied: endoscopische chirurgie)
Nijmegen, Netherlands
United Kingdom
The Royal Surrey County Hospital NHS Trust
Surrey, United Kingdom
Sponsors and Collaborators
Ethicon Endo-Surgery

Publications:
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Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT02278640    
Other Study ID Numbers: ENG-14-002
First Posted: October 30, 2014    Key Record Dates
Results First Posted: August 19, 2016
Last Update Posted: August 19, 2016
Last Verified: July 2016