N/A
N=265
A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices
Pediatric Procedures · Adult Hepato-pancreato-biliary (HPB) Procedures · Adult Lower Gastrointestinal Procedures · Adult Gastric Procedures · Adult Gynecological Procedures
Bottom Line
View on ClinicalTrials.gov: NCT05039021 ↗Enrolled (actual)
265
Serious AEs
6.0%
Results posted
Mar 2025
Primary outcome: Primary: Number of Vessels Transected With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale — 484 Vessels transected
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HARMONIC 1100 Shears (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Ethicon Endo-Surgery
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Vessels Transected With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale |
484 | — |
| PRIMARY Number of Participants With Device-related Adverse Events (AEs) |
5 | — |
| SECONDARY Number of Vessels Transections With Diameter >5 to 7 mm With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale |
174 | — |
| SECONDARY Number of Participants Using HARMONIC 1100 Shears For Sealing and Transection of Lymphatic Vessels as Assessed by Surgeon Satisfaction Scale Score |
76; 25; 0; 0; 3 | — |
| SECONDARY Number of Vessels Transected With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale |
475; 2; 7; 5 | — |
| SECONDARY Number of Grade 4 Vessel Transections Requiring Hemostasis Measures |
4; 1; 0; 0; 1; 1 | — |
Summary
This prospective, single-arm, multi-center study will collect clinical data in a post-market setting for the pediatric population (general surgical procedures) and adult population (general, gynecological, urological, and thoracic surgical procedures). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the HARMONIC 1100 Shears and Generator G11 instructions for use.
Eligibility Criteria
Inclusion Criteria
Pediatric population:
- Non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 1100 Shears per the IFU;
- Less than 18 years of age at the time of procedure; and
- The subject's parent/legal guardian must be willing to give permission for the subject to participate in the study and provide written informed consent for the subject. In addition, assent must be obtained from pediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the study. If the pediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the study), the parent/legal guardian's written informed consent for the subject will be acceptable for the subject to be included in the study.
Adult population:
- Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 1100 Shears per the IFU;
- Willingness to give consent and comply with all study-related evaluations and visit schedule; and
- At least 18 years of age.
Exclusion Criteria
Preoperative
- Physical or psychological condition which would impair study participation;
- Female subjects, of childbearing age, who are pregnant; or
- Enrollment in a concurrent interventional clinical study that could impact the study endpoints.
Intraoperative
- The HARMONIC 1100 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure.
Data sourced from ClinicalTrials.gov (NCT05039021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.