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Harmonic ACE®+7 Shears in Laparoscopic Hysterectomy
NCT02278640 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02278640 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Other, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02278640?
The interventions under investigation include: Harmonic ACE®+7 Shears (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02278640?
This trial is sponsored by Ethicon Endo-Surgery, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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