Status:
COMPLETED
Harmonic ACE®+7 Shears in Laparoscopic Colectomy
Lead Sponsor:
Ethicon Endo-Surgery
Conditions:
Benign or Malignant Disease Indicated for Colectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 laparo...
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 Varia...
Eligibility Criteria
Inclusion
- Indicated for elective laparoscopic colectomy
- Planned dissection and transection of the IMA
- Age: equal to or more than18 years
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02248246
Start Date
August 1 2014
End Date
June 1 2015
Last Update
July 29 2016
Active Locations (4)
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1
Jackson Medical Group
Miami, Florida, United States, 33173
2
Colorectal Surgical Associates Ltd, LLP
Houston, Texas, United States, 77054
3
Ziekenhuis Oost-Limburg, Dept of Surgical Oncology
Genk, Belgium, 3600
4
The Royal Surrey County Hospital NHS Trust
Guildford, Surrey, United Kingdom, GU2 7XX