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

Colectomy; Gynecological; Thoracic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441178
• Other study ID #: ENG-17-001
• Status: Completed
• Phase: N/A
• Start date: March 13, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: August 2020
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: August 30, 2019
• Est. primary completion date: August 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colectomy; Gynecological; Thoracic

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Yeovil District Hospital	Yeovil
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Intraoperative, after vessel has been transected
Secondary	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).	Intraoperative, after vessel has been transected
Secondary	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).	Intraoperative, after vessel has been transected
Secondary	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).	Intraoperative, after vessel has been transected