A Phase 4 interventional study of Harmonic ACE®+7 Shears in Benign or Malignant Disease Indicated for Colectomy, sponsored by Ethicon Endo-Surgery. Completed at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-29.
Sponsored by Ethicon Endo-Surgery · Phase 4, Interventional, and Treatment
This is a prospective, non-randomized, single arm, multicenter, observational study to assess the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing during laparoscopic colectomy. The study will not modify or influence current surgeon technique. Investigators will perform each procedure using the device in compliance with their standard surgical approach and product labeling.
The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled, calibrated, and/or used in accordance with manufacturer design specifications, product instructions and guidelines.
Study Population: Subjects enrolled into this study will undergo elective laparoscopic colectomy wherein dissection and transection of the (inferior mesenteric artery) IMA is indicated.
Primary Variable: Incidence of hemostasis at the IMA Secondary Endpoint: Incidence of hemostasis at the inferior mesenteric vain (IMV).
Definition: Hemostasis of the IMA and 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 IMA and IMV.
Additional exploratory endpoints include:
The percentage of subjects requiring additional measures to obtain hemostasis on the IMA and/or IMV, if identified:
Summary of the use of additional treatment after first pass hemostasis has already been achieved at the IMA and IMV. Graded as yes or no; if "yes", the type, number/volume, time of application (24 hour clock) and rationale for use.
Adverse events attributed to the study device or procedure will be collected from time of surgery to Visit 4 (Approximately 4 weeks after study surgery or as per standard of care (SOC)).
Sample size: No formal sample size determination is required for this study. Approximately 40 subjects from the United States and the European Union are planned to be enrolled into this study.
Global indication for use of the The Harmonic ACE®+7, 5mm Diameter Shears with Advanced Hemostasis:
Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7mm in diameter, using the Advanced Hemostasis function.
Ethicon Endo-Surgery is the lead sponsor of 47 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Preoperative exclusion criteria:
Any Subject unwilling to sign the study informed consent document
Intra-operative exclusion criteria:
Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection
Device: 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
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.
Time frame: Intraoperatively
Percentage of Participants With Hemostasis at the IMV
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.
Time frame: Intraoperatively
| Milestone | Colectomy With Harmonic ACE®+7 Shears |
|---|---|
| Started | 40 |
| Completed | 40 |
| Not completed | 0 |
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.
| percentage of subjects | Colectomy With Harmonic ACE®+7 Shears |
|---|---|
| Percentage of Participants With Hemostasis at the IMA | 100.0 (91.2 to 100.0) |
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.
| percentage of participants | Colectomy With Harmonic ACE®+7 Shears |
|---|---|
| Percentage of Participants With Hemostasis at the IMV | 97.5 (86.8 to 99.9) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Colectomy With Harmonic ACE®+7 Shears | — | 5/40 (12.5%) | 20/40 (50%) |
| Event | Colectomy With Harmonic ACE®+7 Shears |
|---|---|
| Small intestinal obstructionGastrointestinal disorders | 2/40 |
| Postoperative ileusInjury, poisoning and procedural complications | 2/40 |
| AnemiaBlood and lymphatic system disorders | 1/40 |
| Gastrointestinal anastomotic leakInjury, poisoning and procedural complications | 1/40 |
| Procedural haemorrhageInjury, poisoning and procedural complications | 1/40 |
| Splenic haematomaInjury, poisoning and procedural complications | 1/40 |
| Event | Colectomy With Harmonic ACE®+7 Shears |
|---|---|
| NauseaGastrointestinal disorders | 9/40 |
| PainGeneral disorders | 7/40 |
| VomitingGastrointestinal disorders | 4/40 |
| Procedural painInjury, poisoning and procedural complications | 4/40 |
| Wound infectionInfections and infestations | 2/40 |
Safety Set - all subjects in whom the procedure was started.
| Age, Continuous(years) | Colectomy With Harmonic ACE®+7 Shears |
|---|---|
| Mean | 59.8 ± 13.3 |
| Sex: Female, Male(Participants) | Colectomy With Harmonic ACE®+7 Shears |
|---|---|
| Female | 24 |
| Male | 16 |
| Race (NIH/OMB)(Participants) | Colectomy With Harmonic ACE®+7 Shears |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 40 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Colectomy With Harmonic ACE®+7 Shears |
|---|---|
| Belgium | 15 |
| United States | 14 |
| United Kingdom | 11 |
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Ethicon Endo-Surgery