Trial Outcomes & Findings for Harmonic ACE®+7 Shears in Laparoscopic Colectomy (NCT NCT02248246)

NCT ID: NCT02248246

Last Updated: 2016-07-29

Results Overview

Hemostasis of the IMA is a dichotomous variable (i.e. yes or no). "Yes" is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMA.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: Intraoperatively
• Results posted on: 2016-07-29

Participant Flow

Participant milestones

Measure	Colectomy With Harmonic ACE®+7 Shears Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels: * Inferior mesenteric artery (IMA) * Inferior mesenteric vein (IMV) (if identified)
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Harmonic ACE®+7 Shears in Laparoscopic Colectomy

Baseline characteristics by cohort

Measure	Colectomy With Harmonic ACE®+7 Shears n=40 Participants Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels: * Inferior mesenteric artery (IMA) * Inferior mesenteric vein (IMV) (if identified)
Age, Continuous	59.8 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	40 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
Region of Enrollment Belgium	15 participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants
Region of Enrollment United Kingdom	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Intraoperatively

Population: Safety Set - all subjects in whom the procedure was started.

Hemostasis of the IMA is a dichotomous variable (i.e. yes or no). "Yes" is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMA.

Outcome measures

Measure	Colectomy With Harmonic ACE®+7 Shears n=40 Participants Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels: * Inferior mesenteric artery (IMA) * Inferior mesenteric vein (IMV) (if identified)
Percentage of Participants With Hemostasis at the IMA	100.0 percentage of subjects Interval 91.2 to 100.0

SECONDARY outcome

Timeframe: Intraoperatively

Population: Safety Set - all subjects in whom the procedure was started.

Hemostasis of the IMV is a dichotomous variable (i.e. yes or no). "Yes" is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMV.

Outcome measures

Measure	Colectomy With Harmonic ACE®+7 Shears n=40 Participants Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels: * Inferior mesenteric artery (IMA) * Inferior mesenteric vein (IMV) (if identified)
Percentage of Participants With Hemostasis at the IMV	97.5 percentage of participants Interval 86.8 to 99.9

Adverse Events

Colectomy With Harmonic ACE®+7 Shears

Serious events: 5 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Colectomy With Harmonic ACE®+7 Shears n=40 participants at risk Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels: * Inferior mesenteric artery (IMA) * Inferior mesenteric vein (IMV) (if identified)
Blood and lymphatic system disorders Anemia	2.5% 1/40 • Number of events 1
Gastrointestinal disorders Small intestinal obstruction	5.0% 2/40 • Number of events 2
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	2.5% 1/40 • Number of events 1
Injury, poisoning and procedural complications Postoperative ileus	5.0% 2/40 • Number of events 2
Injury, poisoning and procedural complications Procedural haemorrhage	2.5% 1/40 • Number of events 1
Injury, poisoning and procedural complications Splenic haematoma	2.5% 1/40 • Number of events 1

Other adverse events

Measure	Colectomy With Harmonic ACE®+7 Shears n=40 participants at risk Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels: * Inferior mesenteric artery (IMA) * Inferior mesenteric vein (IMV) (if identified)
Gastrointestinal disorders Nausea	22.5% 9/40
Gastrointestinal disorders Vomiting	10.0% 4/40
General disorders Pain	17.5% 7/40
Infections and infestations Wound infection	5.0% 2/40
Injury, poisoning and procedural complications Procedural pain	10.0% 4/40

Additional Information

Michael Schwiers

Ethicon

Phone: 513-337-1172

Email: mschwier@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PIs agreed that the first publication of results should be made in conjunction with the presentation of a joint, multicenter publication of the results with all PIs contributing data, analyses, and comments. If this publication was not submitted within 12 months after conclusion of the Study at all sites, or after Sponsor confirmed there would be no multicenter Study publication, whichever is first, the PIs could have published the results from their individual sites.
• Publication restrictions are in place

Restriction type: OTHER