Colectomy; Gynecological; ThoracicNCT03441178

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

A study testing ENSEAL X1 in people with Colectomy; Gynecological; Thoracic, run by Ethicon Endo-Surgery at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Colectomy; Gynecological; Thoracic
What is being tested?: ENSEAL X1
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 6 sitesin 2 countries
Study dates: 13 Mar 2018to 30 Aug 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;
Willingness to give consent and comply with all study-related evaluations and treatment schedule; and
At least 18 years of age.

Who cannot join

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

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

United Kingdom5 sites

Queen Elizabeth Hospital
Birmingham, B15 2TH
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Western General Hospital
Edinburgh, EH4 2XU
Glasgow Royal Infirmary
Glasgow, G4 0SF
Yeovil District Hospital
Yeovil, BA21 4AT

Other trials in United Kingdom

United States1 site

Indiana University
Indianapolis, Indiana, 46202

Other trials in United States

About this study

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.

Read the detailed 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.

Conditions: Colectomy; Gynecological; Thoracic
Being tested: ENSEAL X1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ENSEAL X1Device
ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.

Study groups in NCT03441178
Study group	Role	What they receive
Colectomy/Gynecological/Thoracic	Experimental	Any colectomy/gynecological/thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use. Receives: Device: ENSEAL X1

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Intraoperative, after vessel has been transected

Secondary outcomes (3)

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).
Measured: 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).
Measured: 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).
Measured: Intraoperative, after vessel has been transected

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 201830 Aug 2019

First posted22 Feb 2018
Study start13 Mar 2018
Primary completion14 Aug 2019
Study completion30 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colectomy; Gynecological; ThoracicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03441178
Sponsor's protocol ID: ENG-17-001
Status last verified: Aug 2020
First submitted: 15 Feb 2018
Last updated: 16 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer
ClinicalTrials.gov ID: NCT03441178
Acronym / sponsor ID: ENG-17-001
Conditions: Colectomy; Gynecological; Thoracic
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
Study start: 13 Mar 2018 (actual)
Primary completion: 14 Aug 2019 (actual)
Study completion: 30 Aug 2019 (actual)
First posted: 22 Feb 2018 (actual)
Results: Posted 16 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Colectomy/Gynecological/Thoracic	Experimental	Device: ENSEAL X1Any colectomy/gynecological/thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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;
Willingness to give consent and comply with all study-related evaluations and treatment schedule; and
At least 18 years of age.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ENSEAL X1ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.	Device	Colectomy/Gynecological/Thoracic

Primary outcome

Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1
Time frame: Intraoperative, after vessel has been transected
* 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).

3 secondary outcomes

Hemostasis Grading Assessment for Each Vessel Transection
Time frame: Intraoperative, after vessel has been transected
Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up
Time frame: Intraoperative, after vessel has been transected
Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used
Time frame: Intraoperative, after vessel has been transected

Results and safety

Results posted to the registry on 16 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Colectomy	36	36
Gynecological	44	43
Thoracic	21	20

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

Time frame: Intraoperative, after vessel has been transected. Number (95% Confidence Interval). Unit: Percentage of Vessels

Measure	Colectomy n = 36	Gynecological n = 44	Thoracic n = 21	Total n = 101
Value	100.0 (94.7 to 100.0)	94.2 (89.3 to 97.3)	96.7 (90.6 to 99.3)	96.2 (93.4 to 98.0)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 Weeks Post Procedure. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ENSEAL X1 Large Jaw Tissue Sealer	12 of 101 (11.9%)	43 of 101 (42.6%)	1 of 101

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bruce Robb, MD principal investigator

Indiana University

6 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ENSEAL X1 in people with Colectomy; Gynecological; Thoracic, run by Ethicon Endo-Surgery at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1 (time frame: Intraoperative, after vessel has been transected). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03441178.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.