Harmonic ACE®+7 Shears in Laparoscopic Hysterectomy

Launched by ETHICON ENDO-SURGERY · Oct 29, 2014

Keywords

ClinConnect Summary

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 vasculat...

Gender

FEMALE

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:
• • 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