At a glance
ClinicalIndex Comparison RecordN/ACompleted· 145 enrolled
Drug / intervention
ENSEAL X1 Curved Jawdevice
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 Upper Gastrointestinal, Lower Gastrointestinal, and Gynecological Procedures
In Brief
A clinical study evaluating ENSEAL X1 Curved Jaw for Upper GI; Lower GI; Gynecological. Completed, enrolled 145 participants across 6 sites in 3 countries.
Detailed Summary
This prospective, single-arm, multi-center study will collect clinical data in a post-market setting by procedure group (upper gastrointestinal \[GI\], lower GI, and gynecological). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 Curved Jaw and Generator G11 instructions for use.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUpper GI; Lower GI; Gynecological
CountriesItaly, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedFeb 2021
Enrollment StartApr 2021
Primary CompletionAug 2023
Study CompletionSep 2023
TodayJul 2026
First PostedFeb 21, 2021
Enrollment StartApr 22, 2021
Primary CompletionAug 30, 2023
Study CompletionSep 29, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.4 years ago
Interventions
ENSEAL X1 Curved Jawdevice
ENSEAL X1 Curved Jaw is used for vessel transection according to instructions for use.