NCT05039021

A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices

A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears and Generator G11 in Pediatric Surgical Procedures (General) and Adult Surgical Procedures (General, Gynecological, Urological, and Thoracic)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Ethicon Endo-Surgery · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Procedures
• Adult Hepato-pancreato-biliary (HPB) Procedures
• Adult Lower Gastrointestinal Procedures
• Adult Gastric Procedures
• Adult Gynecological Procedures
• Adult Urological Procedures
• Adult Thoracic Procedures

Interventions

Type	Name	Description
DEVICE	HARMONIC 1100 Shears	HARMONIC 1100 Shears is used for vessel transection according to instructions for use.

Timeline

• Start date: 2021-07-29
• Primary completion: 2024-02-04
• Completion: 2024-03-12
• First posted: 2021-09-09
• Last updated: 2025-04-30
• Results posted: 2025-03-12

Locations

7 sites across 3 countries: United States, Canada, United Kingdom

Regulatory

• FDA-regulated device study