CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Harmonic ACE®+7 Shearsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02248246
NCT02248246Phase 4Completed
CompareCT.gov

Prospective, Multicenter, Observational Study Evaluating Vessel Sealing Utilizing the Harmonic ACE®+7 Shears During Laparoscopic Colectomy

Ethicon Endo-Surgery·interventional·Posted Sep 25, 2014·Updated Jul 29, 2016

In Brief

A Phase 4 clinical trial evaluating Harmonic ACE®+7 Shears for Benign or Malignant Disease Indicated for Colectomy. Completed, enrolled 40 participants across 4 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign or Malignant Disease Indicated for Colectomy
CountriesBelgium, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 25, 2014
Enrollment StartAug 1, 2014
Primary CompletionFeb 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.8 years ago

Interventions

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)