Trial Outcomes & Findings for A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer in Select Procedures (NCT NCT04763421)
NCT ID: NCT04763421
Last Updated: 2024-09-24
Results Overview
Number of vessels with \<= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. 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 compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
145 participants
Primary outcome timeframe
On the day of transection (Day 0)
Results posted on
2024-09-24
Participant Flow
Participant milestones
| Measure |
ENSEAL X1 Curved Jaw
All participants were treated with ENSEAL X1 curved jaw device for transection of at least one vessel during laparoscopic or open procedure (upper gastrointestinal \[GI\], lower GI, or gynecological).
|
|---|---|
|
Overall Study
STARTED
|
145
|
|
Overall Study
COMPLETED
|
145
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer in Select Procedures
Baseline characteristics by cohort
| Measure |
ENSEAL X1 Curved Jaw
n=145 Participants
All participants were treated with ENSEAL X1 curved jaw device for transection of at least one vessel during laparoscopic or open procedure (upper gastrointestinal \[GI\], lower GI, or gynecological).
|
|---|---|
|
Age, Continuous
|
55.28 Years
STANDARD_DEVIATION 15.904 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
135 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
133 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: On the day of transection (Day 0)Population: Full Analysis Set (FAS) included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, the number of vessels transected analyzed included all vessels that were transected and analyzed for this outcome measure.
Number of vessels with \<= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. 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 compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products).
Outcome measures
| Measure |
ENSEAL X1 Curved Jaw
n=279 Vessels transected
All participants were treated with ENSEAL X1 curved jaw device for transection of at least one vessel during laparoscopic or open procedure (upper gastrointestinal \[GI\], lower GI, or gynecological).
|
|---|---|
|
Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale
|
279 Vessels transected
|
PRIMARY outcome
Timeframe: From Day 0 up to post-procedure follow up visit (up to 28 days)Population: The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
Number of participants with device-related AEs were reported. Device-related AEs were those AEs identified as having a relationship of possibly, probably, or causally with the study devices.
Outcome measures
| Measure |
ENSEAL X1 Curved Jaw
n=145 Participants
All participants were treated with ENSEAL X1 curved jaw device for transection of at least one vessel during laparoscopic or open procedure (upper gastrointestinal \[GI\], lower GI, or gynecological).
|
|---|---|
|
Number of Participants With Device-related Adverse Events (AEs)
|
2 Participants
|
SECONDARY outcome
Timeframe: On the day of transection (Day 0)Population: FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Number of participants with adhesion removal or division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for adhesion removal or division by ENSEAL X1.
Outcome measures
| Measure |
ENSEAL X1 Curved Jaw
n=49 Participants
All participants were treated with ENSEAL X1 curved jaw device for transection of at least one vessel during laparoscopic or open procedure (upper gastrointestinal \[GI\], lower GI, or gynecological).
|
|---|---|
|
Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Very Dissatisfied
|
0 Participants
|
|
Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Dissatisfied
|
0 Participants
|
|
Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Neither Satisfied or Dissatisfied
|
1 Participants
|
|
Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Satisfied
|
27 Participants
|
|
Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Very Satisfied
|
21 Participants
|
SECONDARY outcome
Timeframe: On the day of transection (Day 0)Population: FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Number of participants with lymphatics bundles division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for lymphatic bundles by ENSEAL X1.
Outcome measures
| Measure |
ENSEAL X1 Curved Jaw
n=27 Participants
All participants were treated with ENSEAL X1 curved jaw device for transection of at least one vessel during laparoscopic or open procedure (upper gastrointestinal \[GI\], lower GI, or gynecological).
|
|---|---|
|
Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Very Dissatisfied
|
0 Participants
|
|
Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Dissatisfied
|
0 Participants
|
|
Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Neither Satisfied or Dissatisfied
|
1 Participants
|
|
Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Satisfied
|
18 Participants
|
|
Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Very Satisfied
|
8 Participants
|
SECONDARY outcome
Timeframe: On the day of transection (Day 0)Population: FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Number of participants with tissues bundles division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues bundles by ENSEAL X1.
Outcome measures
| Measure |
ENSEAL X1 Curved Jaw
n=55 Participants
All participants were treated with ENSEAL X1 curved jaw device for transection of at least one vessel during laparoscopic or open procedure (upper gastrointestinal \[GI\], lower GI, or gynecological).
|
|---|---|
|
Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Very Dissatisfied
|
0 Participants
|
|
Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Dissatisfied
|
0 Participants
|
|
Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Neither Satisfied or Dissatisfied
|
1 Participants
|
|
Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Satisfied
|
26 Participants
|
|
Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Very Satisfied
|
28 Participants
|
SECONDARY outcome
Timeframe: On the day of transection (Day 0)Population: FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Number of participants with tissues grasping using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues grasping by ENSEAL X1.
Outcome measures
| Measure |
ENSEAL X1 Curved Jaw
n=67 Participants
All participants were treated with ENSEAL X1 curved jaw device for transection of at least one vessel during laparoscopic or open procedure (upper gastrointestinal \[GI\], lower GI, or gynecological).
|
|---|---|
|
Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Very Dissatisfied
|
0 Participants
|
|
Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Dissatisfied
|
4 Participants
|
|
Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Neither Satisfied or Dissatisfied
|
9 Participants
|
|
Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Satisfied
|
31 Participants
|
|
Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Very Satisfied
|
23 Participants
|
SECONDARY outcome
Timeframe: On the day of transection (Day 0)Population: FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Number of participants with tissues cutting using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues cutting by ENSEAL X1.
Outcome measures
| Measure |
ENSEAL X1 Curved Jaw
n=87 Participants
All participants were treated with ENSEAL X1 curved jaw device for transection of at least one vessel during laparoscopic or open procedure (upper gastrointestinal \[GI\], lower GI, or gynecological).
|
|---|---|
|
Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Very Dissatisfied
|
1 Participants
|
|
Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Dissatisfied
|
1 Participants
|
|
Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Neither Satisfied or Dissatisfied
|
3 Participants
|
|
Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Satisfied
|
38 Participants
|
|
Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Very Satisfied
|
44 Participants
|
SECONDARY outcome
Timeframe: On the day of transection (Day 0)Population: FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Number of participants with tissues dissection using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues dissection by ENSEAL X1.
Outcome measures
| Measure |
ENSEAL X1 Curved Jaw
n=107 Participants
All participants were treated with ENSEAL X1 curved jaw device for transection of at least one vessel during laparoscopic or open procedure (upper gastrointestinal \[GI\], lower GI, or gynecological).
|
|---|---|
|
Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Dissatisfied
|
0 Participants
|
|
Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Very Dissatisfied
|
0 Participants
|
|
Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Neither Satisfied or Dissatisfied
|
3 Participants
|
|
Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Satisfied
|
59 Participants
|
|
Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Very Satisfied
|
45 Participants
|
SECONDARY outcome
Timeframe: On the day of transection (Day 0)Population: FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, the number of vessels transected analyzed included all vessels that were transected and analyzed for this outcome measure.
Number of vessels with hemostasis (Grade 1 to 4) based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. 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 compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products).
Outcome measures
| Measure |
ENSEAL X1 Curved Jaw
n=279 vessels transected
All participants were treated with ENSEAL X1 curved jaw device for transection of at least one vessel during laparoscopic or open procedure (upper gastrointestinal \[GI\], lower GI, or gynecological).
|
|---|---|
|
Number of Vessels With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale
Grade 1
|
258 vessels transected
|
|
Number of Vessels With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale
Grade 2
|
12 vessels transected
|
|
Number of Vessels With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale
Grade 3
|
9 vessels transected
|
|
Number of Vessels With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale
Grade 4
|
0 vessels transected
|
SECONDARY outcome
Timeframe: On the day of transection (Day 0)Population: FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure.
Percentage of Grade 4 vessel transections requiring hemostasis measures were planned to be reported. Data was not collected and analyzed for this outcome measure because there were no hemostatic grade 4 vessel transections.
Outcome measures
Outcome data not reported
Adverse Events
ENSEAL X1 Curved Jaw
Serious events: 10 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ENSEAL X1 Curved Jaw
n=145 participants at risk
All participants were treated with ENSEAL X1 curved jaw device for transection of at least one vessel during laparoscopic or open procedure (upper gastrointestinal \[GI\], lower GI, or gynecological).
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Gastrointestinal disorders
Ileus
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Infections and infestations
Cellulitis
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Infections and infestations
Septic shock
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Vascular disorders
Lymphatic fistula
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
Other adverse events
| Measure |
ENSEAL X1 Curved Jaw
n=145 participants at risk
All participants were treated with ENSEAL X1 curved jaw device for transection of at least one vessel during laparoscopic or open procedure (upper gastrointestinal \[GI\], lower GI, or gynecological).
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Cardiac disorders
Tachycardia
|
1.4%
2/145 • Number of events 2 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.5%
8/145 • Number of events 8 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.1%
3/145 • Number of events 3 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Gastrointestinal disorders
Constipation
|
4.8%
7/145 • Number of events 7 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
2/145 • Number of events 2 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.4%
2/145 • Number of events 2 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Gastrointestinal disorders
Dysphagia
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Gastrointestinal disorders
Ileus
|
2.8%
4/145 • Number of events 4 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Gastrointestinal disorders
Nausea
|
14.5%
21/145 • Number of events 21 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
10/145 • Number of events 10 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
General disorders
Chest discomfort
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
General disorders
Chest pain
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
General disorders
Chills
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
General disorders
Injection site pruritus
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
General disorders
Pain
|
9.7%
14/145 • Number of events 14 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
General disorders
Pyrexia
|
2.8%
4/145 • Number of events 4 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Infections and infestations
Cystitis
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.4%
2/145 • Number of events 2 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Infections and infestations
Oral candidiasis
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Infections and infestations
Urinary tract infection
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Infections and infestations
Wound infection
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Injury, poisoning and procedural complications
Genital contusion
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
2.1%
3/145 • Number of events 3 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.9%
10/145 • Number of events 10 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.4%
2/145 • Number of events 2 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Investigations
Haemoglobin decreased
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Investigations
Oxygen saturation decreased
|
1.4%
2/145 • Number of events 2 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.1%
3/145 • Number of events 3 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
2/145 • Number of events 2 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Nervous system disorders
Dizziness
|
2.1%
3/145 • Number of events 3 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Nervous system disorders
Paraesthesia
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Psychiatric disorders
Confusional state
|
1.4%
2/145 • Number of events 2 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Psychiatric disorders
Hallucination
|
2.1%
3/145 • Number of events 3 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Renal and urinary disorders
Dysuria
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Vascular disorders
Hypertension
|
0.69%
1/145 • Number of events 1 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
|
Vascular disorders
Hypotension
|
1.4%
2/145 • Number of events 2 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
|
Additional Information
Senior Director of Clinical Affairs
Ethicon Endo-Surgery
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Draft abstracts, manuscripts, and materials for presentation at scientific meetings must be sent to the sponsor at least 60 working days prior to abstract or other relevant submission deadlines. Authorship of publications resulting from this study was based on generally accepted criteria for major medical journals.
- Publication restrictions are in place
Restriction type: OTHER