Harmonic ACE®+7 Shears in Laparoscopic Hysterectomy

Benign Disease Where Total Hysterectomy is Indicated Clinical Trial

Official title:

Prospective, Multicenter, Study Evaluating Vessel Sealing Utilizing the Harmonic ACE®+7 Shears During Total Laparoscopic Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02278640
• Other study ID #: ENG-14-002
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2014
• Last updated: August 3, 2015
• Start date: October 2014
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited Kingdom: Research Ethics CommitteeNetherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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

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 Variable: Incidence of hemostasis at the named vessel/pedicle (UA or UP) on the left side. Incidence of 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:

Incidence of 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.

Incidence of 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).

Incidence of 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Disease Where Total Hysterectomy is Indicated

Intervention

Device:
• Harmonic ACE®+7 Shears
Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature.

Locations

Country	Name	City	State
Netherlands	Gynaecoloog (aandachtsgebied: endoscopische chirurgie)	Nijmegen
United Kingdom	The Royal Surrey County Hospital NHS Trust	Surrey
United States	Florida Hospital Celebration Health	Celebration	Florida
United States	The Advanced Gynecological Surgery Institute	Schaumburg	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Countries where clinical trial is conducted

United States,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hemostasis of the uterine vasculature.	•Incidence of hemostasis at the IMA [Time Frame: Intraoperatively] [Designated as safety issue: No] Hemostasis of the IMA is a dichotomous variable (i.e. yes or no). "Yes" is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMA.	Intraoperative	No