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NCT02248246 · ClinicalTrials.gov registry record · Phase 4
Harmonic ACE®+7 Shears in Laparoscopic Colectomy
A Phase 4 study of Benign or Malignant Disease Indicated for Colectomy, sponsored by Ethicon Endo-Surgery.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 4
- Study locations
NCT02248246: Completed Phase 4 study of Benign or Malignant Disease Indicated for Colectomy, sponsored by Ethicon Endo-Surgery.
NCT02248246 is a Phase 4 study of Benign or Malignant Disease Indicated for Colectomy that has completed, run by Ethicon Endo-Surgery. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02248246, a Phase 4 study of Benign or Malignant Disease Indicated for Colectomy, has completed, sponsored by Ethicon Endo-Surgery.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
Hemostasis of the IMA is a dichotomous variable (i.e. yes or no). "Yes" is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMA.
Conditions Studied
Interventions
- DEVICE Harmonic ACE®+7 Shears
Study Locations (4)
Florida
- Jackson Medical Group - Miami
Texas
- Colorectal Surgical Associates Ltd, LLP - Houston
Other
- Ziekenhuis Oost-Limburg, Dept of Surgical Oncology - Genk
Surrey
- The Royal Surrey County Hospital NHS Trust - Guildford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-06 |
| Phase | Phase 4 |
What the finished NCT02248246 record still lists
NCT02248246 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Benign or Malignant Disease Indicated for Colectomy appearing as the primary indexed condition, and to 1 intervention - of which Harmonic ACE®+7 Shears is the first listed.
NCT02248246 reports a single indexed study location in Florida, Texas, Other.
Frequently Asked Questions
What is clinical trial NCT02248246 about?
NCT02248246 is a clinical study titled "Harmonic ACE®+7 Shears in Laparoscopic Colectomy". 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 wi...
What is the current status of trial NCT02248246?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2014-08. Estimated completion is 2015-06.
What conditions does trial NCT02248246 study?
This clinical trial studies the following conditions: Benign or Malignant Disease Indicated for Colectomy.
What interventions are being tested in trial NCT02248246?
The interventions under investigation include: Harmonic ACE®+7 Shears (DEVICE).
Who is sponsoring clinical trial NCT02248246?
This trial is sponsored by Ethicon Endo-Surgery, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02248246 being conducted?
This trial has 4 study locations across Florida, Texas, Surrey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02248246's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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