CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 265 enrolled
Drug / intervention
HARMONIC 1100 Shearsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05039021
NCT05039021N/ACompleted
CompareCT.gov

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)

Ethicon Endo-Surgery·interventional·Posted Sep 9, 2021·Updated Apr 30, 2025

In Brief

A clinical study evaluating HARMONIC 1100 Shears for Pediatric Procedures and 6 related conditions. Completed, enrolled 265 participants across 7 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPediatric Procedures, Adult Hepato-pancreato-biliary (HPB) Procedures, Adult Lower Gastrointestinal Procedures, Adult Gastric Procedures, Adult Gynecological Procedures, Adult Urological Procedures, Adult Thoracic Procedures
CountriesCanada, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedSep 9, 2021
Enrollment StartJul 29, 2021
Primary CompletionFeb 4, 2024
Study CompletionMar 12, 2024
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 4.8 years ago

Interventions

HARMONIC 1100 Shearsdevice

HARMONIC 1100 Shears is used for vessel transection according to instructions for use.