Phase 4
N=40
Harmonic ACE®+7 Shears in Laparoscopic Hysterectomy
Benign Disease Where Total Hysterectomy is Indicated
Bottom Line
View on ClinicalTrials.gov: NCT02278640 ↗Enrolled (actual)
40
Serious AEs
7.5%
Results posted
Aug 2016
Primary outcome: Primary: Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Left Side. — 97.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Harmonic ACE®+7 Shears (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Ethicon Endo-Surgery
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Left Side. |
97.5 | — |
| PRIMARY Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Right Side. |
92.5 | — |
| SECONDARY Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Left Side. |
100.0 | — |
| SECONDARY Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Right Side. |
100.0 | — |
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
Eligibility 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:
- 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
Data sourced from ClinicalTrials.gov (NCT02278640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.