Trial Outcomes & Findings for A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices (NCT NCT05039021)
NCT ID: NCT05039021
Last Updated: 2025-04-30
Results Overview
Number of vessels transected 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 HARMONIC 1100 Shears; 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
265 participants
Primary outcome timeframe
On the day of transection (Day 0)
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
HARMONIC 1100 Shears
HARMONIC 1100 Shears was used per the Instructions for use (IFUs) in pediatric surgical procedures (general) or adult surgical procedures (general, gynecological, urological, and thoracic) where at least one single vessel was transected.
|
|---|---|
|
Overall Study
STARTED
|
265
|
|
Overall Study
COMPLETED
|
261
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
HARMONIC 1100 Shears
HARMONIC 1100 Shears was used per the Instructions for use (IFUs) in pediatric surgical procedures (general) or adult surgical procedures (general, gynecological, urological, and thoracic) where at least one single vessel was transected.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices
Baseline characteristics by cohort
| Measure |
HARMONIC 1100 Shears
n=265 Participants
HARMONIC 1100 Shears was used per the Instructions for use (IFUs) in pediatric surgical procedures (general) or adult surgical procedures (general, gynecological, urological, and thoracic) where at least one single vessel was transected.
|
|---|---|
|
Age, Continuous
|
53.73 years
STANDARD_DEVIATION 22.793 • n=5 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
224 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 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
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
213 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: On the day of transection (Day 0)Population: Full analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel. Here, "Overall number of units analyzed" signifies total number of vessels transected and analyzed for this outcome measure.
Number of vessels transected 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 HARMONIC 1100 Shears; 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 |
HARMONIC 1100 Shears
n=489 Vessels transected
HARMONIC 1100 Shears was used per the Instructions for use (IFUs) in pediatric surgical procedures (general) or adult surgical procedures (general, gynecological, urological, and thoracic) where at least one single vessel was transected.
|
|---|---|
|
Number of Vessels Transected With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale
|
484 Vessels transected
|
PRIMARY outcome
Timeframe: From Day 0 up to post-procedure follow up visit (up to 28 days)Population: Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
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 device. Possible refers to the relationship with the use of the device is weak but cannot be ruled out completely; Probable refers to the relationship with the use of the device seems relevant and/or the event cannot reasonably be explained by another cause, but additional information may be obtained; Causal relationship refers to the event is associated with the device or with procedures beyond reasonable doubt.
Outcome measures
| Measure |
HARMONIC 1100 Shears
n=265 Participants
HARMONIC 1100 Shears was used per the Instructions for use (IFUs) in pediatric surgical procedures (general) or adult surgical procedures (general, gynecological, urological, and thoracic) where at least one single vessel was transected.
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|---|---|
|
Number of Participants With Device-related Adverse Events (AEs)
|
5 Participants
|
SECONDARY outcome
Timeframe: On the day of transection (Day 0)Population: Full analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel. Here, "Overall number of units analyzed" signifies total number of vessels transected and analyzed for this outcome measure.
Number of vessels transected with diameter \>5 to 7 mm 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 HARMONIC 1100 Shears; 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 |
HARMONIC 1100 Shears
n=489 Vessels transected
HARMONIC 1100 Shears was used per the Instructions for use (IFUs) in pediatric surgical procedures (general) or adult surgical procedures (general, gynecological, urological, and thoracic) where at least one single vessel was transected.
|
|---|---|
|
Number of Vessels Transections With Diameter >5 to 7 mm With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale
|
174 Vessels transected
|
SECONDARY outcome
Timeframe: On the day of transection (Day 0)Population: Analysis population included participants in FAS with sealing and transection of lymphatic vessels by HARMONIC 1100 Shears.
Number of participants using HARMONIC 1100 Shears for sealing and transection of lymphatic vessels 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 sealing and transection of lymphatic vessel by HARMONIC 1100 Shears.
Outcome measures
| Measure |
HARMONIC 1100 Shears
n=104 Participants
HARMONIC 1100 Shears was used per the Instructions for use (IFUs) in pediatric surgical procedures (general) or adult surgical procedures (general, gynecological, urological, and thoracic) where at least one single vessel was transected.
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|---|---|
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Number of Participants Using HARMONIC 1100 Shears For Sealing and Transection of Lymphatic Vessels as Assessed by Surgeon Satisfaction Scale Score
Very Satisfied
|
76 Participants
|
|
Number of Participants Using HARMONIC 1100 Shears For Sealing and Transection of Lymphatic Vessels as Assessed by Surgeon Satisfaction Scale Score
Satisfied
|
25 Participants
|
|
Number of Participants Using HARMONIC 1100 Shears For Sealing and Transection of Lymphatic Vessels as Assessed by Surgeon Satisfaction Scale Score
Neither Satisfied or Dissatisfied
|
0 Participants
|
|
Number of Participants Using HARMONIC 1100 Shears For Sealing and Transection of Lymphatic Vessels as Assessed by Surgeon Satisfaction Scale Score
Dissatisfied
|
0 Participants
|
|
Number of Participants Using HARMONIC 1100 Shears For Sealing and Transection of Lymphatic Vessels as Assessed by Surgeon Satisfaction Scale Score
Very Dissatisfied
|
3 Participants
|
SECONDARY outcome
Timeframe: On the day of transection (Day 0)Population: Full analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel. Here, "Overall number of units analyzed" signifies total number of vessels transected and analyzed for this outcome measure.
Number of vessels transected with hemostasis (Grade 1 to 4) based on hemostasis grading scale was 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 HARMONIC 1100 Shears; 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 |
HARMONIC 1100 Shears
n=489 Vessels transected
HARMONIC 1100 Shears was used per the Instructions for use (IFUs) in pediatric surgical procedures (general) or adult surgical procedures (general, gynecological, urological, and thoracic) where at least one single vessel was transected.
|
|---|---|
|
Number of Vessels Transected With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale
Grade 1
|
475 Vessels transected
|
|
Number of Vessels Transected With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale
Grade 2
|
2 Vessels transected
|
|
Number of Vessels Transected With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale
Grade 3
|
7 Vessels transected
|
|
Number of Vessels Transected With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale
Grade 4
|
5 Vessels transected
|
SECONDARY outcome
Timeframe: On the day of transection (Day 0)Population: Full analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, "Overall number of units analyzed" signifies Grade 4 vessels transections.
Number of Grade 4 vessel transections requiring hemostasis measures such as hemoclips, staples, sutures, fibrin sealants, adjunctive topical hemostats (except fibrin sealants), other advanced energy products and other products 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 HARMONIC 1100 Shears; or Grade 4: significant bleeding (pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (hemoclips, staples, sutures, fibrin sealants, adjunctive topical hemostats (except fibrin sealants), other advanced energy products). Since multiple responses were collected, sum of the data of each category exceeds the overall number of units analyzed.
Outcome measures
| Measure |
HARMONIC 1100 Shears
n=5 Vessels transected
HARMONIC 1100 Shears was used per the Instructions for use (IFUs) in pediatric surgical procedures (general) or adult surgical procedures (general, gynecological, urological, and thoracic) where at least one single vessel was transected.
|
|---|---|
|
Number of Grade 4 Vessel Transections Requiring Hemostasis Measures
Hemoclips
|
4 Vessels transected
|
|
Number of Grade 4 Vessel Transections Requiring Hemostasis Measures
Staples
|
1 Vessels transected
|
|
Number of Grade 4 Vessel Transections Requiring Hemostasis Measures
Sutures
|
0 Vessels transected
|
|
Number of Grade 4 Vessel Transections Requiring Hemostasis Measures
Fibrin Sealants
|
0 Vessels transected
|
|
Number of Grade 4 Vessel Transections Requiring Hemostasis Measures
Adjunctive Topical Hemostats (except Fibrin Sealants)
|
1 Vessels transected
|
|
Number of Grade 4 Vessel Transections Requiring Hemostasis Measures
Other Advanced Energy Products
|
1 Vessels transected
|
|
Number of Grade 4 Vessel Transections Requiring Hemostasis Measures
Other
|
1 Vessels transected
|
Adverse Events
HARMONIC 1100 Shears
Serious events: 16 serious events
Other events: 69 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
HARMONIC 1100 Shears
n=265 participants at risk
HARMONIC 1100 Shears was used per the Instructions for use (IFUs) in pediatric surgical procedures (general) or adult surgical procedures (general, gynecological, urological, and thoracic) where at least one single vessel was transected.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Cardiac disorders
Pericardial effusion
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Cardiac disorders
Tachycardia
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Nausea
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.75%
2/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Infections and infestations
Empyema
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Infections and infestations
Pneumonia
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Infections and infestations
Post procedural pneumonia
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.75%
2/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Vascular disorders
Circulatory collapse
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Vascular disorders
Hypotension
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
Other adverse events
| Measure |
HARMONIC 1100 Shears
n=265 participants at risk
HARMONIC 1100 Shears was used per the Instructions for use (IFUs) in pediatric surgical procedures (general) or adult surgical procedures (general, gynecological, urological, and thoracic) where at least one single vessel was transected.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
4/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Cardiac disorders
Atrial fibrillation
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Cardiac disorders
Tachycardia
|
0.75%
2/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.1%
3/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
7/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
1.5%
4/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Constipation
|
0.75%
2/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Haematemesis
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Ileus
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Nausea
|
3.4%
9/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Odynophagia
|
0.75%
2/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Retching
|
0.75%
2/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
3/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
General disorders
Chest pain
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
General disorders
Hernia
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
General disorders
Pain
|
3.0%
8/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
General disorders
Pyrexia
|
1.1%
3/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Infections and infestations
Bronchitis
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Infections and infestations
Cystitis
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Infections and infestations
Fungaemia
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Infections and infestations
Pneumonia
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Infections and infestations
Postoperative wound infection
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Infections and infestations
Urinary tract infection
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Infections and infestations
Wound infection
|
1.9%
5/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Anastomotic haemorrhage
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Confusion postoperative
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Incision site pruritus
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Incision site vesicles
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Penis injury
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.9%
5/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.1%
3/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
1.1%
3/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Investigations
Aspiration pleural cavity
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Investigations
Blood glucose increased
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Investigations
Creatinine renal clearance decreased
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Investigations
Glomerular filtration rate decreased
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Investigations
Haemoglobin decreased
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Investigations
Oxygen saturation decreased
|
0.75%
2/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Investigations
Urine output decreased
|
0.75%
2/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
3/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.75%
2/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Nervous system disorders
Dizziness
|
0.75%
2/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Nervous system disorders
Somnolence
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Renal and urinary disorders
Bladder discomfort
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Renal and urinary disorders
Dysuria
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Renal and urinary disorders
Haematuria
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Reproductive system and breast disorders
Breast pain
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.1%
3/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.75%
2/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.75%
2/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.5%
4/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Vascular disorders
Arterial haemorrhage
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Vascular disorders
Haemorrhage
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Vascular disorders
Hot flush
|
0.38%
1/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Vascular disorders
Hypertension
|
0.75%
2/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
|
Vascular disorders
Hypotension
|
1.5%
4/265 • From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
|
Additional Information
Senior Director Medical Affair-Endomechanical and Trx
Ethicon Endo-Surgery, Inc.
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