Trial Outcomes & Findings for A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures (NCT NCT05067647)

Last Updated: 2023-12-21

Results Overview

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). Here, the number of vessels that achieved \<=Grade 3 hemostasis was reported.

Recruitment status

COMPLETED

Study phase

Target enrollment

94 participants

Primary outcome timeframe

On the day of transection (Day 0)

Results posted on

2023-12-21

Participant Flow

Participant milestones

Participant milestones
Measure	ENSEAL X1 All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures.
Overall Study STARTED	94
Overall Study COMPLETED	93
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ENSEAL X1 All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures.
Overall Study Lost to Follow-up	1

Baseline Characteristics

A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ENSEAL X1 n=94 Participants All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures.
Age, Continuous	63.4 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	89 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	61 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	0 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: On the day of transection (Day 0)

Population: ENSEAL X1 analysis set included all participants whose vessels were transected and analyzed during the procedures. Here, the number of vessels transected analyzed included all vessels that were transected and analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	ENSEAL X1 n=112 vessels transected All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures.
Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale	108 vessels transected

PRIMARY outcome

Timeframe: Baseline up to 6 weeks

Population: ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.

Device-related AEs were those having a relationship of possibly, probably, or causally. 1. Possible-The relationship with use of device was weak but cannot be ruled out completely. Alternative causes were also possible. Cases where relatedness cannot be assessed, or no information had been obtained were also classified as possible. 2. Probable -The relationship with use of device seemed relevant and/or event cannot reasonably be explained by another cause, but additional information may be obtained; 3. Causal relationship-The event was associated with device or with procedures beyond reasonable doubt with event occurred such as, a known side effect; temporal relationship; involves a body-site or organ that device was applied or had an effect on; followed a known response pattern; impact on event when discontinued and reintroduced; Others; Harms due to error in use.

Outcome measures

Outcome measures
Measure	ENSEAL X1 n=94 Participants All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures.
Number of Participants With at Least One Device-related Adverse Events (AEs)	4 Participants

SECONDARY outcome

Timeframe: On the day of transection (Day 0)

Population: ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures. Here, the number of participants analyzed included participants who were analyzed only for this outcome measure.

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

Outcome measures
Measure	ENSEAL X1 n=13 Participants All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures.
Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Very dissatisfied	1 Participants
Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Dissatisfied	2 Participants
Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Neither Satisfied or Dissatisfied	0 Participants
Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Satisfied	6 Participants
Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Very Satisfied	4 Participants

SECONDARY outcome

Timeframe: On the day of transection (Day 0)

Outcome measures

Outcome measures
Measure	ENSEAL X1 n=36 Participants All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures.
Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Very dissatisfied	1 Participants
Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Dissatisfied	1 Participants
Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Neither Satisfied or Dissatisfied	6 Participants
Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Satisfied	21 Participants
Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Very Satisfied	7 Participants

SECONDARY outcome

Timeframe: On the day of transection (Day 0)

Outcome measures

Outcome measures
Measure	ENSEAL X1 n=57 Participants All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures.
Number of Participants With Tissue Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Very dissatisfied	2 Participants
Number of Participants With Tissue Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Dissatisfied	1 Participants
Number of Participants With Tissue Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Neither Satisfied or Dissatisfied	10 Participants
Number of Participants With Tissue Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Satisfied	33 Participants
Number of Participants With Tissue Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Very Satisfied	11 Participants

SECONDARY outcome

Timeframe: On the day of transection (Day 0)

Outcome measures

Outcome measures
Measure	ENSEAL X1 n=27 Participants All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures.
Number of Participants With Tissue Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Very dissatisfied	1 Participants
Number of Participants With Tissue Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Dissatisfied	0 Participants
Number of Participants With Tissue Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Neither Satisfied or Dissatisfied	3 Participants
Number of Participants With Tissue Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Satisfied	13 Participants
Number of Participants With Tissue Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Very Satisfied	10 Participants

SECONDARY outcome

Timeframe: On the day of transection (Day 0)

Outcome measures

Outcome measures
Measure	ENSEAL X1 n=58 Participants All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures.
Number of Participants With Tissue Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Satisfied	39 Participants
Number of Participants With Tissue Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Very dissatisfied	1 Participants
Number of Participants With Tissue Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Dissatisfied	3 Participants
Number of Participants With Tissue Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Neither Satisfied or Dissatisfied	6 Participants
Number of Participants With Tissue Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Very Satisfied	9 Participants

SECONDARY outcome

Timeframe: On the day of transection (Day 0)

Outcome measures

Outcome measures
Measure	ENSEAL X1 n=52 Participants All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures.
Number of Participants With Tissue Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Very dissatisfied	0 Participants
Number of Participants With Tissue Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Dissatisfied	6 Participants
Number of Participants With Tissue Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Neither Satisfied or Dissatisfied	8 Participants
Number of Participants With Tissue Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Satisfied	31 Participants
Number of Participants With Tissue Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Very Satisfied	7 Participants

SECONDARY outcome

Timeframe: On the day of transection (Day 0)

Outcome measures

Outcome measures
Measure	ENSEAL X1 n=112 vessels transected All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures.
Number of Vessels With Hemostasis (Grade 1 to 4) Based on Grading Scale Grade 1	104 vessels transected
Number of Vessels With Hemostasis (Grade 1 to 4) Based on Grading Scale Grade 2	0 vessels transected
Number of Vessels With Hemostasis (Grade 1 to 4) Based on Grading Scale Grade 3	4 vessels transected
Number of Vessels With Hemostasis (Grade 1 to 4) Based on Grading Scale Grade 4	4 vessels transected

SECONDARY outcome

Timeframe: On the day of transection (Day 0)

Population: ENSEAL X1 analysis set included all participants whose vessels were transected and analyzed during the procedures. Here, the number of participants analyzed included participants who were analyzed only for this outcome measure and the number of vessels transected analyzed included only vessels that were transected and analyzed for this outcome measure.

Percentage of grade 4 vessel transections requiring hemostasis measures such as sutures and hemoclips were reported.

Outcome measures

Outcome measures
Measure	ENSEAL X1 n=4 vessels transected All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures.
Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures Such as Sutures and Hemoclips Sutures	50.0 percentage of vessel transections
Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures Such as Sutures and Hemoclips Hemoclips	50.0 percentage of vessel transections

Adverse Events

ENSEAL X1

Serious events: 4 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ENSEAL X1 n=94 participants at risk All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures.
Infections and infestations Escherichia urinary tract infection	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Injury, poisoning and procedural complications Post procedural haemorrhage	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Metabolism and nutrition disorders Hypocalcaemia	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Respiratory, thoracic and mediastinal disorders Chylothorax	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.

Other adverse events

Other adverse events
Measure	ENSEAL X1 n=94 participants at risk All participants were treated with ENSEAL X1 device for transection of at least one vessel during thoracic, urologic, or ENT procedures.
Cardiac disorders Atrial fibrillation	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Cardiac disorders Bradycardia	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Cardiac disorders Sinus tachycardia	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Cardiac disorders Tachycardia	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Gastrointestinal disorders Abdominal distension	2.1% 2/94 • Number of events 2 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Gastrointestinal disorders Abdominal pain	7.4% 7/94 • Number of events 7 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Gastrointestinal disorders Abdominal pain lower	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Gastrointestinal disorders Abdominal pain upper	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Gastrointestinal disorders Abdominal tenderness	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Gastrointestinal disorders Constipation	6.4% 6/94 • Number of events 8 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Gastrointestinal disorders Diarrhoea	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Gastrointestinal disorders Dyspepsia	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Gastrointestinal disorders Flatulence	2.1% 2/94 • Number of events 2 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.1% 1/94 • Number of events 2 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Gastrointestinal disorders Ileus paralytic	2.1% 2/94 • Number of events 2 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Gastrointestinal disorders Intestinal obstruction	2.1% 2/94 • Number of events 2 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Gastrointestinal disorders Nausea	6.4% 6/94 • Number of events 6 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Gastrointestinal disorders Vomiting	6.4% 6/94 • Number of events 6 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
General disorders Catheter site extravasation	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
General disorders Chest pain	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
General disorders Oedema	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
General disorders Oedema peripheral	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
General disorders Pain	4.3% 4/94 • Number of events 4 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
General disorders Pyrexia	2.1% 2/94 • Number of events 2 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
General disorders Suprapubic pain	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Infections and infestations Escherichia urinary tract infection	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Infections and infestations Pneumonia	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Infections and infestations Sepsis	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Injury, poisoning and procedural complications Confusion postoperative	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Injury, poisoning and procedural complications Contusion	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Injury, poisoning and procedural complications Drain site complication	1.1% 1/94 • Number of events 2 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Injury, poisoning and procedural complications Post procedural constipation	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Injury, poisoning and procedural complications Post procedural hypotension	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Injury, poisoning and procedural complications Procedural nausea	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Injury, poisoning and procedural complications Procedural pain	7.4% 7/94 • Number of events 7 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Injury, poisoning and procedural complications Wound complication	9.6% 9/94 • Number of events 9 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Injury, poisoning and procedural complications Wound dehiscence	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Injury, poisoning and procedural complications Wound secretion	2.1% 2/94 • Number of events 2 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Investigations Blood albumin decreased	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Investigations Blood creatinine increased	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Investigations Haemoglobin decreased	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Investigations Heart rate increased	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Investigations Oxygen consumption increased	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Investigations Oxygen saturation decreased	2.1% 2/94 • Number of events 2 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Investigations Urine output	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Investigations Urine output decreased	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Metabolism and nutrition disorders Electrolyte imbalance	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Metabolism and nutrition disorders Hyperkalaemia	3.2% 3/94 • Number of events 3 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Metabolism and nutrition disorders Hyponatraemia	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Musculoskeletal and connective tissue disorders Back pain	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Musculoskeletal and connective tissue disorders Flank pain	3.2% 3/94 • Number of events 3 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Musculoskeletal and connective tissue disorders Mobility decreased	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.1% 2/94 • Number of events 2 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Nervous system disorders Dizziness	4.3% 4/94 • Number of events 4 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Nervous system disorders Dizziness postural	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Nervous system disorders Hypoaesthesia	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Nervous system disorders Petit mal epilepsy	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Nervous system disorders Presyncope	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Psychiatric disorders Confusional state	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Psychiatric disorders Hallucination	2.1% 2/94 • Number of events 2 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Renal and urinary disorders Acute kidney injury	2.1% 2/94 • Number of events 2 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Renal and urinary disorders Dysuria	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Renal and urinary disorders Haematuria	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Renal and urinary disorders Urinary retention	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Reproductive system and breast disorders Testicular pain	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Skin and subcutaneous tissue disorders Blister	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Skin and subcutaneous tissue disorders Dermatitis allergic	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Skin and subcutaneous tissue disorders Rash	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Vascular disorders Haematoma	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Vascular disorders Hypotension	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.
Vascular disorders Venous haemorrhage	1.1% 1/94 • Number of events 1 • Baseline up to 6 weeks ENSEAL X1 analysis set included all participants who utilized ENSEAL X1 device during the procedures.

Additional Information

MEDICAL DIRECTOR LCM Compliance

Ethicon Endo-Surgery, Inc.

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER