Benign Disease Where Total Hysterectomy is IndicatedPhase 4NCT02278640
Harmonic ACE®+7 Shears in Laparoscopic Hysterectomy
A Phase 4 study testing Harmonic ACE®+7 Shears in people with Benign Disease Where Total Hysterectomy is Indicated, run by Ethicon Endo-Surgery at 4 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Benign Disease Where Total Hysterectomy is Indicated
- What is being tested?
- Harmonic ACE®+7 Shears
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Oct 2014to Jun 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Florida Hospital Celebration Health
Celebration, Florida, 34747
The Advanced Gynecological Surgery Institute
Schaumburg, Illinois, 60173
Netherlands1 site
Gynaecoloog (aandachtsgebied: endoscopische chirurgie)
Nijmegen
About this study
Official title: Prospective, Multicenter, Study Evaluating Vessel Sealing Utilizing the Harmonic ACE®+7 Shears During Total Laparoscopic Hysterectomy
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
Read the 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.
- Being tested
- Harmonic ACE®+7 Shears
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmonic ACE®+7 ShearsDevice
Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature.
| Study group | Role | What they receive |
|---|---|---|
| Harmonic ACE®+7 Shears | Other | Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy Receives: Device: Harmonic ACE®+7 Shears |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Intraoperative
Secondary outcomes (2)
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.
Measured: 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.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Disease Where Total Hysterectomy is IndicatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278640
- Sponsor's protocol ID
- ENG-14-002
- Status last verified
- Jul 2016
- First submitted
- 10 Oct 2014
- Last updated
- 19 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27124666
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Study Evaluating Vessel Sealing Utilizing the Harmonic ACE®+7 Shears During Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT02278640
- Acronym / sponsor ID
- ENG-14-002
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Oct 2014 (estimated)
- Results
- Posted 19 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Harmonic ACE®+7 Shears | Other | Device: Harmonic ACE®+7 ShearsSingle Arm study using Harmonic ACE for dissection and transection in Hysterectomy |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Harmonic ACE®+7 ShearsVessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature. | Device | Harmonic ACE®+7 Shears |
Primary outcome
Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Left Side.
Time frame: Intraoperative
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.
Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Right Side.
Time frame: Intraoperative
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.
2 secondary outcomes
Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Left Side.
Time frame: Intraoperative
Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Right Side.
Time frame: Intraoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27124666Nieboer 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Harmonic ACE®+7 Shears in people with Benign Disease Where Total Hysterectomy is Indicated, run by Ethicon Endo-Surgery at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Left Side. (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02278640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.