Phase 4
N=40
Harmonic ACE®+7 Shears in Laparoscopic Colectomy
Benign or Malignant Disease Indicated for Colectomy
Bottom Line
View on ClinicalTrials.gov: NCT02248246 ↗Enrolled (actual)
40
Serious AEs
12.5%
Results posted
Apr 2016
Primary outcome: Primary: Percentage of Participants With Hemostasis at the IMA — 100.0 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Harmonic ACE®+7 Shears (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ethicon Endo-Surgery
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hemostasis at the IMA |
100.0 | — |
| SECONDARY Percentage of Participants With Hemostasis at the IMV |
97.5 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- Indicated for elective laparoscopic colectomy
- Planned dissection and transection of the IMA
- Age: equal to or more than18 years
Exclusion Criteria
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
Data sourced from ClinicalTrials.gov (NCT02248246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.