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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 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. The trial reports 4 study locations across 3 states.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02278640
The ClinicalTrials.gov registry entry for NCT02278640 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 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 4 study locations spanning 3 distinct geographic areas - top geographies include 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.
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