Clinical trial NCT02278640: Harmonic ACE®+7 Shears in Laparoscopic Hysterectomy
Official title: Prospective, Multicenter, Study Evaluating Vessel Sealing Utilizing the Harmonic ACE®+7 Shears During Total Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Disease Where Total Hysterectomy is Indicated
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2014-10-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

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 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 vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device.

Note: Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed.

Secondary Endpoints:

Percentage of subjects achieving hemostasis at the OP on the left and/or right side.

If the study procedure also includes the transection and sealing of one or both OPs, hemostasis of the left and/or right OP will also be recorded. Hemostasis of the OP is a dichotomous variable (i.e. yes or no). "Yes" is defined as the hemostatic transection of the ovarian vasculature (left and/or right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.).

Note: Multiple applications of the Advanced Hemostasis mode or the device in a MAX or MIN mode are allowed.

Exploratory endpoints include:

Requirement for additional measures to obtain hemostasis on the named vessel/pedicle (UA or UP and/or OP) on the left and right side Use of other energy devices (tissue sealers, cautery devices) - Graded as yes or no; if "yes", the name and type, time of application (24 hour clock).

Use of additional hemostatic products (e.g. hemoclips, staples, sutures, fibrin sealants) - Graded as yes or no; if "yes", the name and type, number/volume, and time of application (24 hour clock).

Complications associated with vaginal cuff healing including dehiscence or separation, infection, cellulitis, abscess, inflammation, and granulation associated with each suture used as part of the study.

Adverse events attributed to the study device or procedure will be collected from time of surgery to Visit 4 (Approximately 4 to 6 weeks after study surgery or as per standard of care (SOC)).

No formal sample size determination is required for this study. Approximately 40 subjects from the United States and the European Union are planned to be enrolled into this study.

Global indication for use of the The Harmonic ACE®+7, 5mm Diameter Shears with Advanced Hemostasis:

Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7mm in diameter, using the Advanced Hemostasis function.

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

Primary outcomes:
measure: Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Left Side.
timeFrame: Intraoperative
measure: Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Right Side.
timeFrame: Intraoperative
Secondary outcomes:
measure: Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Left Side.
timeFrame: Intraoperative
measure: Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Right Side.
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Celebration
country: United States
facility: Florida Hospital Celebration Health
state: Florida
city: Schaumburg
country: United States
facility: The Advanced Gynecological Surgery Institute
state: Illinois
city: Nijmegen
country: Netherlands
facility: Gynaecoloog (aandachtsgebied: endoscopische chirurgie)
city: Surrey
country: United Kingdom
facility: The Royal Surrey County Hospital NHS Trust
Study officials:
References:
citation: Nieboer TE, Steller CJ, Hinoul P, Maxson AJ, Schwiers ML, Miller CE, Coppus SF, Kent AS. Clinical utility of a novel ultrasonic vessel sealing device in transecting and sealing large vessels during laparoscopic hysterectomy using advanced hemostasis mode. Eur J Obstet Gynecol Reprod Biol. 2016 Jun;201:135-9. doi: 10.1016/j.ejogrb.2016.03.035. Epub 2016 Apr 14.