A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer

Ethicon

Status: Completed

Conditions: Colectomy; Gynecological; Thoracic

Treatments: Device: ENSEAL X1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03441178

ENG-17-001

Details and patient eligibility

About

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.

Full description

The primary objective of this study is to prospectively generate device specific clinical data related to hemostasis in a post-market setting using the ENSEAL X1 per its instructions for use. There will be no blinding or planned interim analysis in this study.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Elective procedure (colectomy, gynecological, or thoracic) where at least one vessel is planned to be transected by the ENSEAL X1 device per its instructions for use;
2. Willingness to give consent and comply with all study-related evaluations and treatment schedule; and
3. At least 18 years of age.

Exclusion criteria

1. Physical or psychological condition which would impair study participation; or
2. Enrollment in a concurrent clinical study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

Colectomy/Gynecological/Thoracic

Experimental group

Description:

Any colectomy/gynecological/thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.

Treatment:

Device: ENSEAL X1