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Harmonic ACE®+7 Shears in Laparoscopic Colectomy

NCT02248246 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-07-29

Study results available
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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.

Conditions

  • Benign or Malignant Disease Indicated for Colectomy

Interventions

DEVICE

Harmonic ACE®+7 Shears

Vessel sealing performance assessed for transection and sealing of the following named vessels: * Inferior mesenteric artery (IMA) * Inferior mesenteric vein (IMV) (if identified)

Sponsors & Collaborators

  • Ethicon Endo-Surgery

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-02-28
Completion
2015-06-30

Countries

  • United States
  • Belgium
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02248246 on ClinicalTrials.gov