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NCT06608485 · ClinicalTrials.gov registry record
A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures
A clinical trial of Adult Gynecological Procedures and Adult Urological Procedures, sponsored by Ethicon Endo-Surgery.
- Recruiting
- Registry status
- 165
- Enrollment target
- 9
- Study locations
NCT06608485: Recruiting study of Adult Gynecological Procedures and Adult Urological Procedures, sponsored by Ethicon Endo-Surgery.
NCT06608485 is a study of Adult Gynecological Procedures and Adult Urological Procedures that is actively recruiting participants, run by Ethicon Endo-Surgery. The registered enrollment target is 165 participants. The trial reports 9 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06608485, a study of Adult Gynecological Procedures and Adult Urological Procedures, is actively recruiting participants, sponsored by Ethicon Endo-Surgery.
- RECRUITING
- Registry status
- 165 participants
- Enrollment target
- 9
- Study locations
Study Summary
The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market setting when used per the instructions for use in pediatric and adult surgical procedures.
Primary Outcome
Number of vessel transection with achievement of Grade 3 or lower hemostasis for each vessel transection will be reported as per the grading scale as follows- Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, basic energy devices (monopolar and/or bipolar) and/or touch-ups with HARMONIC 700 Shears; Grade 4: significant bleeding (for example \[e.g
Conditions Studied
Interventions
- DEVICE HARMONIC 700 Shears
Study Locations (9)
Other
- Dorset County Hospital Nhs Foundation Trust - Dorchester
- Western General Hospital - Edinburgh
- Southampton General Hospital - Southampton
- Yeovil District Hospital - Yeovil
Indiana
- Riley Hospital for Children at Indiana University Health - Indianapolis
Kansas
- NextStage Clinical Research - Wichita
New York
- Icahn School of Medicine at Mt. Sinai - New York
Texas
- The Methodist Hospital Research Institute D B A Houston Methodist Research Institute - Houston
Quebec
- Centre Hospitalier de l'Universite de Montreal - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2025-01-23 |
| Est. Completion | 2026-08-15 |
What NCT06608485 shows while recruiting
NCT06608485 is an observational study that tracks outcomes without assigning an intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap.
The record links to 5 conditions, with Adult Gynecological Procedures appearing as the primary indexed condition, and to 1 intervention - of which HARMONIC 700 Shears is the first listed.
NCT06608485 lists 9 locations in 6 states (Other, Indiana, Kansas).
Frequently Asked Questions
What is clinical trial NCT06608485 about?
NCT06608485 is a clinical study titled "A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures". The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market setting when used per the instructions for use in pediatric and adult surgical procedures.
What is the current status of trial NCT06608485?
This trial is currently recruiting. The enrollment target is 165 participants. The study started on 2025-01-23. Estimated completion is 2026-08-15.
What conditions does trial NCT06608485 study?
This clinical trial studies the following conditions: Adult Gynecological Procedures, Adult Urological Procedures, Adult Thoracic Procedures, Pediatric Surgical Procedures, Adult Surgical Procedures.
What interventions are being tested in trial NCT06608485?
The interventions under investigation include: HARMONIC 700 Shears (DEVICE).
Who is sponsoring clinical trial NCT06608485?
This trial is sponsored by Ethicon Endo-Surgery, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06608485 being conducted?
This trial has 9 study locations across Indiana, Kansas, New York, Texas, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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