Status:
COMPLETED
Harmonic ACE®+7 Shears in Laparoscopic Hysterectomy
Lead Sponsor:
Ethicon Endo-Surgery
Conditions:
Benign Disease Where Total Hysterectomy is Indicated
Eligibility:
FEMALE
40+ years
Phase:
PHASE4
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 h...
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 indica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02278640
Start Date
October 1 2014
End Date
June 1 2015
Last Update
August 19 2016
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Florida Hospital Celebration Health
Celebration, Florida, United States, 34747
2
The Advanced Gynecological Surgery Institute
Schaumburg, Illinois, United States, 60173
3
Gynaecoloog (aandachtsgebied: endoscopische chirurgie)
Nijmegen, Netherlands
4
The Royal Surrey County Hospital NHS Trust
Surrey, United Kingdom