At a glance
ClinicalIndex Comparison RecordN/ACompleted· 101 enrolled
Drug / intervention
ENSEAL X1device
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, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer
In Brief
A clinical study evaluating ENSEAL X1 for Colectomy; Gynecological; Thoracic. Completed, enrolled 101 participants across 6 sites in 2 countries.
Detailed Summary
This prospective, single-arm, multi-center, evaluation will collect clinical data in a post-market setting. The three types of procedures studied will be colectomy, gynecological, and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 instructions for use.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColectomy; Gynecological; Thoracic
CountriesUnited Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 2018
Enrollment StartMar 2018
Primary CompletionAug 2019
Study CompletionAug 2019
TodayJul 2026
First PostedFeb 22, 2018
Enrollment StartMar 13, 2018
Primary CompletionAug 14, 2019
Study CompletionAug 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.4 years ago
Interventions
ENSEAL X1device
ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.