Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 4 study locations across 4 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02248246
The ClinicalTrials.gov registry entry for NCT02248246 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ethicon Endo-Surgery, which has 39 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 4 distinct geographic areas - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.