NCT03441178 - A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer | Crick

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

101

Conditions

Colectomy; Gynecological; Thoracic

Interventions

ENSEAL X1DEVICE

ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Indiana University

Indianapolis, Indiana, United States

Queen Elizabeth Hospital

Birmingham, United Kingdom

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Western General Hospital

Edinburgh, United Kingdom

Outcomes

Primary Outcomes

Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1

* Grade 1: no bleeding at transection site; * Grade 2: minor bleeding at transection site, no intervention needed; * Grade 3: minor bleeding at transection site, mild intervention needed, use of monopolar device and/or touch-ups with ENSEAL X1; * Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).

Time frame: Intraoperative, after vessel has been transected

Secondary Outcomes

Hemostasis Grading Assessment for Each Vessel Transection

* Grade 1: no bleeding at transection site; * Grade 2: minor bleeding at transection site, no intervention needed; * Grade 3: minor bleeding at transection site, mild intervention needed, use of monopolar device and/or touch-ups with ENSEAL X1; * Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).

Time frame: Intraoperative, after vessel has been transected

Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up

* Grade 1: no bleeding at transection site; * Grade 2: minor bleeding at transection site, no intervention needed; * Grade 3: minor bleeding at transection site, mild intervention needed, use of monopolar device and/or touch-ups with ENSEAL X1; * Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).

Time frame: Intraoperative, after vessel has been transected

Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used

* Grade 1: no bleeding at transection site; * Grade 2: minor bleeding at transection site, no intervention needed; * Grade 3: minor bleeding at transection site, mild intervention needed, use of monopolar device and/or touch-ups with ENSEAL X1; * Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).