At a glance
ClinicalIndex Comparison RecordN/ACompleted· 94 enrolled
Drug / intervention
ENSEAL X1 Curved Jaw Tissue Sealerdevice
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.
A Prospective, Single-Arm Multi-Center Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures
In Brief
A clinical study evaluating ENSEAL X1 Curved Jaw Tissue Sealer for Thoracic Procedure and 2 related conditions. Completed, enrolled 94 participants across 6 sites in 4 countries.
Detailed Summary
The purpose of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 curved jaw tissue sealer and Ethicon endo-surgery generator G11 (GEN11) devices when used per the instructions for use (IFU).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan, Netherlands, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
First PostedOct 2021
Enrollment StartNov 2021
Primary CompletionOct 2022
Study CompletionNov 2022
TodayJul 2026
First PostedOct 5, 2021
Enrollment StartNov 29, 2021
Primary CompletionOct 21, 2022
Study CompletionNov 30, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.7 years ago
Interventions
ENSEAL X1 Curved Jaw Tissue Sealerdevice
ENSEAL X1 curved jaw tissue sealer is used for transecting and sealing vessels during thoracic, urologic, or ENT procedures according to instructions for use.