At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective, Multicenter, Study Evaluating Vessel Sealing Utilizing the Harmonic ACE®+7 Shears During Total Laparoscopic Hysterectomy
In Brief
A Phase 4 clinical trial evaluating Harmonic ACE®+7 Shears for Benign Disease Where Total Hysterectomy is Indicated. Completed, enrolled 40 participants across 4 sites in 3 countries.
Detailed 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
Study Details
Timeline
Interventions
Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature.