Trial Outcomes & Findings for Harmonic ACE®+7 Shears in Laparoscopic Hysterectomy (NCT NCT02278640)

Last Updated: 2016-08-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

Intraoperative

Results posted on

2016-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Harmonic ACE®+7 Shears in Laparoscopic Hysterectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Harmonic ACE®+7 Shears n=40 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.
Age, Continuous	48.5 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Netherlands	15 participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
Region of Enrollment United Kingdom	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Intraoperative

Population: Safety Set - all subjects in whom the procedure was started.

Outcome measures

Outcome measures
Measure	Harmonic ACE®+7 Shears n=40 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.
Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Left Side.	97.5 percentage of participants Interval 86.8 to 99.9

PRIMARY outcome

Timeframe: Intraoperative

Population: Safety Set - all subjects in whom the procedure was started.

Outcome measures

Outcome measures
Measure	Harmonic ACE®+7 Shears n=40 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.
Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Right Side.	92.5 percentage of participants Interval 79.6 to 98.4

SECONDARY outcome

Timeframe: Intraoperative

Population: Safety Set With OP transection - All subjects in whom the procedure was started and for whom the transection of the ovarian pedicle was attempted.

Outcome measures

Outcome measures
Measure	Harmonic ACE®+7 Shears n=23 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.
Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Left Side.	100.0 percentage of participants Interval 85.2 to 100.0

SECONDARY outcome

Timeframe: Intraoperative

Population: Safety Set With OP transection - All subjects in whom the procedure was started and for whom the transection of the ovarian pedicle was attempted.

Outcome measures

Outcome measures
Measure	Harmonic ACE®+7 Shears n=23 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.
Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Right Side.	100.0 percentage of participants Interval 85.2 to 100.0

Adverse Events

Harmonic ACE®+7 Shears

Serious events: 3 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Harmonic ACE®+7 Shears n=40 participants at risk 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.
Infections and infestations Haematoma infection	2.5% 1/40 • Number of events 1 • Surgery to 4 weeks post surgery
Renal and urinary disorders Urinary retention	2.5% 1/40 • Number of events 1 • Surgery to 4 weeks post surgery
Reproductive system and breast disorders Vaginal haemorrhage	2.5% 1/40 • Number of events 1 • Surgery to 4 weeks post surgery

Other adverse events

Other adverse events
Measure	Harmonic ACE®+7 Shears n=40 participants at risk 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.
Gastrointestinal disorders Abdominal pain	7.5% 3/40 • Number of events 3 • Surgery to 4 weeks post surgery
Gastrointestinal disorders Constipation	12.5% 5/40 • Number of events 5 • Surgery to 4 weeks post surgery
Gastrointestinal disorders Nausea	17.5% 7/40 • Number of events 7 • Surgery to 4 weeks post surgery
Gastrointestinal disorders Vomiting	7.5% 3/40 • Number of events 3 • Surgery to 4 weeks post surgery
General disorders Pain	7.5% 3/40 • Number of events 3 • Surgery to 4 weeks post surgery
General disorders Pyrexia	5.0% 2/40 • Number of events 2 • Surgery to 4 weeks post surgery
Infections and infestations Postoperative wound infection	5.0% 2/40 • Number of events 2 • Surgery to 4 weeks post surgery
Injury, poisoning and procedural complications Procedural nausea	5.0% 2/40 • Number of events 2 • Surgery to 4 weeks post surgery
Injury, poisoning and procedural complications Procedural pain	22.5% 9/40 • Number of events 9 • Surgery to 4 weeks post surgery

Additional Information

Michael Schwiers, Principal Biostatistician

Ethicon Endo-Surgery

Phone: 513-337-1172

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER