Trial Outcomes & Findings for A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer (NCT NCT03441178)
NCT ID: NCT03441178
Last Updated: 2020-09-16
Results Overview
* 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).
COMPLETED
NA
101 participants
Intraoperative, after vessel has been transected
2020-09-16
Participant Flow
Planned on 100 enrolled but 101 was enrolled due to timing and study closure.
Participant milestones
| Measure |
Colectomy
Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
Gynecological
Any gynecological procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
Thoracic
Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
44
|
21
|
|
Overall Study
COMPLETED
|
36
|
43
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer
Baseline characteristics by cohort
| Measure |
ENSEAL X1 Large Jaw Tissue Sealer
n=101 Participants
Use of the ENSEAL X1 Large Jaw Tissue Sealer
|
|---|---|
|
Age, Continuous
|
61.8 Years
STANDARD_DEVIATION 12.5 • n=93 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Colectomy
n=68 Vessels Transected
Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
Gynecological
n=156 Vessels Transected
Any gynecological procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
Thoracic
n=90 Vessels Transected
Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
Total
n=314 Vessels Transected
Any colectomy, gynecological or thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
|---|---|---|---|---|
|
Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1
|
100.0 Percentage of Vessels
Interval 94.7 to 100.0
|
94.2 Percentage of Vessels
Interval 89.3 to 97.3
|
96.7 Percentage of Vessels
Interval 90.6 to 99.3
|
96.2 Percentage of Vessels
Interval 93.4 to 98.0
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Colectomy
n=68 Vessels Transected
Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
Gynecological
n=156 Vessels Transected
Any gynecological procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
Thoracic
n=90 Vessels Transected
Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
Total
n=314 Vessels Transected
Any colectomy, gynecological or thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
|---|---|---|---|---|
|
Hemostasis Grading Assessment for Each Vessel Transection
Grade 1
|
63 Vessels Transected
|
126 Vessels Transected
|
81 Vessels Transected
|
270 Vessels Transected
|
|
Hemostasis Grading Assessment for Each Vessel Transection
Grade 2
|
4 Vessels Transected
|
14 Vessels Transected
|
3 Vessels Transected
|
21 Vessels Transected
|
|
Hemostasis Grading Assessment for Each Vessel Transection
Grade 3
|
1 Vessels Transected
|
7 Vessels Transected
|
3 Vessels Transected
|
11 Vessels Transected
|
|
Hemostasis Grading Assessment for Each Vessel Transection
Grade 4
|
0 Vessels Transected
|
9 Vessels Transected
|
3 Vessels Transected
|
12 Vessels Transected
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Colectomy
n=1 Grade 3 Vessels
Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
Gynecological
n=7 Grade 3 Vessels
Any gynecological procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
Thoracic
n=3 Grade 3 Vessels
Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
Total
n=11 Grade 3 Vessels
Any colectomy, gynecological or thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
|---|---|---|---|---|
|
Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up
|
0 Vessels Transected
|
7 Vessels Transected
|
1 Vessels Transected
|
8 Vessels Transected
|
SECONDARY outcome
Timeframe: Intraoperative, after vessel has been transectedPopulation: There were no Grade 4 vessels seen in the colectomy procedures.
* 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).
Outcome measures
| Measure |
Colectomy
n=9 Grade 4 Vessels
Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
Gynecological
n=3 Grade 4 Vessels
Any gynecological procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
Thoracic
n=12 Grade 4 Vessels
Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
Total
Any colectomy, gynecological or thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
|
|---|---|---|---|---|
|
Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used
Left uterine artery and vein (suture)
|
2 Vessels Transected
|
0 Vessels Transected
|
2 Vessels Transected
|
—
|
|
Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used
Left uterine artery (suture)
|
2 Vessels Transected
|
0 Vessels Transected
|
2 Vessels Transected
|
—
|
|
Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used
Right uterine artery (suture)
|
4 Vessels Transected
|
0 Vessels Transected
|
4 Vessels Transected
|
—
|
|
Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used
Right ovarian artery (suture)
|
1 Vessels Transected
|
0 Vessels Transected
|
1 Vessels Transected
|
—
|
|
Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used
Short gastric (suture -1; hemoclip -1)
|
0 Vessels Transected
|
2 Vessels Transected
|
2 Vessels Transected
|
—
|
|
Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used
Gastroepiploic (suture)
|
0 Vessels Transected
|
1 Vessels Transected
|
1 Vessels Transected
|
—
|
Adverse Events
ENSEAL X1 Large Jaw Tissue Sealer
Serious adverse events
| Measure |
ENSEAL X1 Large Jaw Tissue Sealer
n=101 participants at risk
Use of the ENSEAL X1 Large Jaw Tissue Sealer
|
|---|---|
|
Gastrointestinal disorders
Ileus paralytic
|
0.99%
1/101 • 4 Weeks Post Procedure
|
|
Infections and infestations
Empyema
|
2.0%
2/101 • 4 Weeks Post Procedure
|
|
Infections and infestations
Lower respiratory tract infection
|
0.99%
1/101 • 4 Weeks Post Procedure
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
3.0%
3/101 • 4 Weeks Post Procedure
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.99%
1/101 • 4 Weeks Post Procedure
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.99%
1/101 • 4 Weeks Post Procedure
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.99%
1/101 • 4 Weeks Post Procedure
|
|
Investigations
Blood creatinine increased
|
0.99%
1/101 • 4 Weeks Post Procedure
|
|
Investigations
Blood potassium increased
|
0.99%
1/101 • 4 Weeks Post Procedure
|
|
Renal and urinary disorders
Acute kidney injury
|
0.99%
1/101 • 4 Weeks Post Procedure
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
2/101 • 4 Weeks Post Procedure
|
Other adverse events
| Measure |
ENSEAL X1 Large Jaw Tissue Sealer
n=101 participants at risk
Use of the ENSEAL X1 Large Jaw Tissue Sealer
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
5.0%
5/101 • 4 Weeks Post Procedure
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
5/101 • 4 Weeks Post Procedure
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
3/101 • 4 Weeks Post Procedure
|
|
General disorders
Pain
|
10.9%
11/101 • 4 Weeks Post Procedure
|
|
General disorders
Pyrexia
|
3.0%
3/101 • 4 Weeks Post Procedure
|
|
Injury, poisoning and procedural complications
Procedural pain
|
15.8%
16/101 • 4 Weeks Post Procedure
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
4.0%
4/101 • 4 Weeks Post Procedure
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
3.0%
3/101 • 4 Weeks Post Procedure
|
|
Renal and urinary disorders
Acute kidney injury
|
3.0%
3/101 • 4 Weeks Post Procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
3/101 • 4 Weeks Post Procedure
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.0%
3/101 • 4 Weeks Post Procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60