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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Harmonic ACE®+7 Shears | Other | Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harmonic ACE®+7 Shears | Device | Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Left Side. | 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. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed. | Intraoperative |
| Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Right Side. | 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. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Left Side. | 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. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed. |
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Inclusion Criteria:
Subjects satisfying all of the following criteria will be considered the screening population and will be eligible for participation in this study:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital Celebration Health | Celebration | Florida | 34747 | United States | ||
| The Advanced Gynecological Surgery Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27124666 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Harmonic ACE®+7 Shears | Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Set - all subjects in whom the procedure was started.
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| ID | Title | Description |
|---|---|---|
| BG000 | Harmonic ACE®+7 Shears | Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Left Side. | 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. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed. | Safety Set - all subjects in whom the procedure was started. | Posted | Number | 95% Confidence Interval | percentage of participants | Intraoperative |
|
Surgery to 4 weeks post surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Harmonic ACE®+7 Shears | Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematoma infection | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Schwiers, Principal Biostatistician | Ethicon Endo-Surgery | 513-337-1172 | mschwier@its.jnj.com |
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| Intraoperative |
| Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Right Side. | 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. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed. | Intraoperative |
| Schaumburg |
| Illinois |
| 60173 |
| United States |
| Gynaecoloog (aandachtsgebied: endoscopische chirurgie) | Nijmegen | Netherlands |
| The Royal Surrey County Hospital NHS Trust | Surrey | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy
Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature.
|
|
| Primary | Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Right Side. | 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. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed. | Safety Set - all subjects in whom the procedure was started. | Posted | Number | 95% Confidence Interval | percentage of participants | Intraoperative |
|
|
|
| Secondary | Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Left Side. | 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. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed. | Safety Set With OP transection - All subjects in whom the procedure was started and for whom the transection of the ovarian pedicle was attempted. | Posted | Number | 95% Confidence Interval | percentage of participants | Intraoperative |
|
|
|
| Secondary | Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Right Side. | 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. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed. | Safety Set With OP transection - All subjects in whom the procedure was started and for whom the transection of the ovarian pedicle was attempted. | Posted | Number | 95% Confidence Interval | percentage of participants | Intraoperative |
|
|
|
| 3 |
| 40 |
| 23 |
| 40 |
| Urinary retention | Renal and urinary disorders | MedDRA v17.0 | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v17.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA v17.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v17.0 | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
|
The PIs agreed that the first publication of results should be made in conjunction with the presentation of a joint, multicenter publication of the results with all PIs contributing data, analyses, and comments. If this publication was not submitted within 12 months after conclusion of the Study at all sites, or after Sponsor confirmed there would be no multicenter Study publication, whichever is first, the PIs could have published the results from their individual sites.