Benign or Malignant Disease Indicated for ColectomyPhase 4NCT02248246
Harmonic ACE®+7 Shears in Laparoscopic Colectomy
A Phase 4 study testing Harmonic ACE®+7 Shears in people with Benign or Malignant Disease Indicated for Colectomy, run by Ethicon Endo-Surgery at 4 sites in 3 countries.
Trial summary
This is a prospective, non-randomized, single arm, multicenter, observational study to assess the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing during laparoscopic colectomy. The study will not modify or influence current surgeon technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign or Malignant Disease Indicated for Colectomy
- 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
- Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indicated for elective laparoscopic colectomy
- Planned dissection and transection of the IMA
- Age: equal to or more than18 years
Who cannot join
- 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, or
- Any Subject unwilling to sign the study informed consent document
- Intra-operative exclusion criteria:
- Prior to transection of the IMA, the investigator prospectively concludes the inability to safely isolate and transect the IMA with exclusive use of study device while adhering to the instructions for use, or
- 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
Colorectal Surgical Associates Ltd, LLP
Houston, Texas, 77054
Jackson Medical Group
Miami, Florida, 33173
United Kingdom1 site
The Royal Surrey County Hospital NHS Trust
Guildford, Surrey, GU2 7XX
About this study
Official title: Prospective, Multicenter, Observational Study Evaluating Vessel Sealing Utilizing the Harmonic ACE®+7 Shears During Laparoscopic Colectomy
This is a prospective, non-randomized, single arm, multicenter, observational study to assess the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing during laparoscopic colectomy. 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 laparoscopic colectomy wherein dissection and transection of the (inferior mesenteric artery) IMA is indicated.
Primary Variable: Incidence of hemostasis at the IMA Secondary Endpoint: Incidence of hemostasis at the inferior mesenteric vain (IMV).
Definition: Hemostasis of the IMA and IMV 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 and IMV.
Additional exploratory endpoints include:
The percentage of subjects requiring additional measures to obtain hemostasis on the IMA and/or IMV, if identified:
- Number of Harmonic touch ups - frequency of Harmonic reapplications required due to oozing or bleeding at initial transection of named vessels
- Use of other energy devices (tissue sealers, cautery devices) - Graded as yes or no; if "yes", the type, transection time (using stopwatch), time of application (24 hour clock)
- Use of hemostatic products (e.g. hemoclips, staples, sutures, fibrin sealants) - Graded as yes or no; if "yes", the type and name of product, number/volume, and time of application (24 hour clock)
Summary of the use of additional treatment after first pass hemostasis has already been achieved at the IMA and IMV. Graded as yes or no; if "yes", the type, number/volume, time of application (24 hour clock) and rationale for use.
Adverse events attributed to the study device or procedure will be collected from time of surgery to Visit 4 (Approximately 4 weeks after study surgery or as per standard of care (SOC)).
Sample size: 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
- Keywords
- Hemostasis, Harmonic ACE®+7 Shears, Laparoscopic, Inferior mesenteric artery, Inferior mesenteric vein, Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmonic ACE®+7 ShearsDevice
Vessel sealing performance assessed for transection and sealing of the following named vessels:
- Inferior mesenteric artery (IMA)
- Inferior mesenteric vein (IMV) (if identified)
| Study group | Role | What they receive |
|---|---|---|
| Colectomy with Harmonic ACE®+7 Shears | Other | Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection 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 Participants With Hemostasis at the IMA
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.
Measured: Intraoperatively
Secondary outcomes (1)
Percentage of Participants With Hemostasis at the IMV
Hemostasis of the IMV 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 IMV.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 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 or Malignant Disease Indicated for ColectomyStudies 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
- NCT02248246
- Sponsor's protocol ID
- ENG-14-001
- Status last verified
- Jun 2016
- First submitted
- 22 Sep 2014
- Last updated
- 29 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Plasencia G, Van der Speeten K, Hinoul P, Kelch JA, Batiller J, Severin KS, Schwiers ML, Rockall T. Large-Vessel Sealing in Laparoscopic Colectomy with an Ultrasonic Device. JSLS. 2016 Apr-Jun;20(2):e2016.00010. doi: 10.4293/JSLS.2016.00010.
PubMed 27186065
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Observational Study Evaluating Vessel Sealing Utilizing the Harmonic ACE®+7 Shears During Laparoscopic Colectomy
- ClinicalTrials.gov ID
- NCT02248246
- Acronym / sponsor ID
- ENG-14-001
- Keywords
- Hemostasis, Harmonic ACE®+7 Shears, Laparoscopic, Inferior mesenteric artery, Inferior mesenteric vein, Observational
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Posted 1 Apr 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, observational study to assess the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing during laparoscopic colectomy. 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 laparoscopic colectomy wherein dissection and transection of the (inferior mesenteric artery) IMA is indicated.
Primary Variable: Incidence of hemostasis at the IMA Secondary Endpoint: Incidence of hemostasis at the inferior mesenteric vain (IMV).
Definition: Hemostasis of the IMA and IMV 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 and IMV.
Additional exploratory endpoints include:
The percentage of subjects requiring additional measures to obtain hemostasis on the IMA and/or IMV, if identified:
- Number of Harmonic touch ups - frequency of Harmonic reapplications required due to oozing or bleeding at initial transection of named vessels
- Use of other energy devices (tissue sealers, cautery devices) - Graded as yes or no; if "yes", the type, transection time (using stopwatch), time of application (24 hour clock)
- Use of hemostatic products (e.g. hemoclips, staples, sutures, fibrin sealants) - Graded as yes or no; if "yes", the type and name of product, number/volume, and time of application (24 hour clock)
Summary of the use of additional treatment after first pass hemostasis has already been achieved at the IMA and IMV. Graded as yes or no; if "yes", the type, number/volume, time of application (24 hour clock) and rationale for use.
Adverse events attributed to the study device or procedure will be collected from time of surgery to Visit 4 (Approximately 4 weeks after study surgery or as per standard of care (SOC)).
Sample size: 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 |
|---|---|---|
| Colectomy with Harmonic ACE®+7 Shears | Other | Device: Harmonic ACE®+7 ShearsLaparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indicated for elective laparoscopic colectomy
- Planned dissection and transection of the IMA
- Age: equal to or more than18 years
Key exclusion criteria (8 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, or
- Any Subject unwilling to sign the study informed consent document
- Prior to transection of the IMA, the investigator prospectively concludes the inability to safely isolate and transect the IMA with exclusive use of study device while adhering to the instructions for use, or
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 sealing performance assessed for transection and sealing of the following named vessels: * Inferior mesenteric artery (IMA) * Inferior mesenteric vein (IMV) (if identified) | Device | Colectomy with Harmonic ACE®+7 Shears |
Primary outcome
Percentage of Participants With Hemostasis at the IMA
Time frame: Intraoperatively
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.
1 secondary outcome
Percentage of Participants With Hemostasis at the IMV
Time frame: Intraoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27186065Plasencia G, Van der Speeten K, Hinoul P, Kelch JA, Batiller J, Severin KS, Schwiers ML, Rockall T. Large-Vessel Sealing in Laparoscopic Colectomy with an Ultrasonic Device. JSLS. 2016 Apr-Jun;20(2):e2016.00010. doi: 10.4293/JSLS.2016.00010.
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 or Malignant Disease Indicated for Colectomy, 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 8 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 29 Jul 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, Belgium, 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 1 Apr 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 Participants With Hemostasis at the IMA (time frame: Intraoperatively). 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 NCT02248246, 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 29 Jul 2016.