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NCT02278640 · ClinicalTrials.gov registry record · Phase 4
Harmonic ACE®+7 Shears in Laparoscopic Hysterectomy
A Phase 4 study of Benign Disease Where Total Hysterectomy is Indicated, sponsored by Ethicon Endo-Surgery.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 4
- Study locations
NCT02278640: Completed Phase 4 study of Benign Disease Where Total Hysterectomy is Indicated, sponsored by Ethicon Endo-Surgery.
NCT02278640 is a Phase 4 study of Benign Disease Where Total Hysterectomy is Indicated 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 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02278640, a Phase 4 study of Benign Disease Where Total Hysterectomy is Indicated, 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, study to assess the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing during total laparoscopic hysterectomy. 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 named vessel or pedicle is a dichotomous variable (i.e. yes or no). "Yes" is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications o
Conditions Studied
Interventions
- DEVICE Harmonic ACE®+7 Shears
Study Locations (4)
Other
- Gynaecoloog (aandachtsgebied: endoscopische chirurgie) - Nijmegen
- The Royal Surrey County Hospital NHS Trust - Surrey
Florida
- Florida Hospital Celebration Health - Celebration
Illinois
- The Advanced Gynecological Surgery Institute - Schaumburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-10 |
| Est. Completion | 2015-06 |
| Phase | Phase 4 |
What the finished NCT02278640 record still lists
NCT02278640 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 Disease Where Total Hysterectomy is Indicated appearing as the primary indexed condition, and to 1 intervention - of which Harmonic ACE®+7 Shears is the first listed.
NCT02278640 reports a single indexed study location in Other, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT02278640 about?
NCT02278640 is a clinical study titled "Harmonic ACE®+7 Shears in Laparoscopic Hysterectomy". This is a prospective, non-randomized, single arm, multicenter, study to assess the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing during total laparoscopic hysterectomy. The study will not modify or influence current surgeon technique. Investigators will pe...
What is the current status of trial NCT02278640?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2014-10. Estimated completion is 2015-06.
What conditions does trial NCT02278640 study?
This clinical trial studies the following conditions: Benign Disease Where Total Hysterectomy is Indicated.
What interventions are being tested in trial NCT02278640?
The interventions under investigation include: Harmonic ACE®+7 Shears (DEVICE).
Who is sponsoring clinical trial NCT02278640?
This trial is sponsored by Ethicon Endo-Surgery, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02278640 being conducted?
This trial has 4 study locations across Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02278640's enrollment target sits among peer trials
40 1397th of 2000 higher than 534 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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