Harmonic ACE®+7 Shears in Laparoscopic Colectomy
Completed · Phase 4
Conditions studied: Benign or Malignant Disease Indicated for Colectomy
In brief
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.
Key facts
- Study ID
- NCT02248246
- Run by
- Ethicon Endo-Surgery
- People needed
- 40
- Starts
- 2014-08-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2016-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Indicated for elective laparoscopic colectomy
- Planned dissection and transection of the IMA
- Age: equal to or more than18 years
You may not qualify if…
- 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
Where it is running
- Jackson Medical Group — Miami, Florida, United States
- Colorectal Surgical Associates Ltd, LLP — Houston, Texas, United States
- Ziekenhuis Oost-Limburg, Dept of Surgical Oncology — Genk, Belgium
- The Royal Surrey County Hospital NHS Trust — Guildford, Surrey, United Kingdom
Full record on ClinicalTrials.gov
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