Phase 4 Completed N=40 Treatment

Harmonic ACE®+7 Shears in Laparoscopic Hysterectomy

Benign Disease Where Total Hysterectomy is Indicated

Source: ClinicalTrials.gov NCT02278640 ↗

Enrolled (actual)

Serious AEs

7.5%

Results posted

Aug 2016

Primary outcomePrimary: Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Left Side. — 97.5 percentage of participants

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.