Prospective, Multicenter, Study Evaluating Vessel Sealing Utilizing the Harmonic ACE®+7 Shears During Total Laparoscopic Hysterectomy
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 6
- Primary Endpoint
- Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Left Side.
Study Overview
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
Detailed Description
Study Population: Subjects enrolled into this study will undergo elective total laparoscopic hysterectomy for benign indications wherein dissection and transection of the uterine vasculature is indicated.
Primary Variables: Percentage of subjects achieving hemostasis at the named vessel/pedicle (UA or UP) on the left side. Percentage of subjects achieving hemostasis at the named vessel/pedicle (UA or UP) on the right side.
Definition: 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.
Note: 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 Endpoints:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects satisfying all of the following criteria will be considered the screening population and will be eligible for participation in this study:
- •Indicated for elective total laparoscopic hysterectomy
- •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:
- •Known or suspected uncontrolled bleeding disorders
- •Subjects unlikely to comply with protocol procedures or adhere to the study visit schedule
- •Any condition rendering a subject unable to understand the nature, scope, and possible consequences of the study or study procedures
- •Any Subject unwilling to sign the study informed consent document
- •Any suspected malignancy
- •Any Subject of childbearing potential with a positive or serum pregnancy test within 24 hours prior to surgery
- •Intra-operative exclusion criteria:
- •Any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
Outcomes
Primary Outcomes
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.
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 Outcomes
- Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Left Side.(Intraoperative)
- Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Right Side.(Intraoperative)