Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colectomy with Harmonic ACE®+7 Shears | Other | Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harmonic ACE®+7 Shears | Device | Vessel sealing performance assessed for transection and sealing of the following named vessels:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperatively |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Preoperative exclusion criteria:
Known or suspected uncontrolled bleeding disorders
Subjects unlikely to comply with protocol procedures or adhere to the study visit schedule
Any condition rendering a subject unable to understand the nature, scope, and possible consequences of the study or study procedures, or
Any Subject unwilling to sign the study informed consent document
Intra-operative exclusion criteria:
Prior to transection of the IMA, the investigator prospectively concludes the inability to safely isolate and transect the IMA with exclusive use of study device while adhering to the instructions for use, or
Any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jackson Medical Group | Miami | Florida | 33173 | United States | ||
| Colorectal Surgical Associates Ltd, LLP |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27186065 | Background | Plasencia G, Van der Speeten K, Hinoul P, Kelch JA, Batiller J, Severin KS, Schwiers ML, Rockall T. Large-Vessel Sealing in Laparoscopic Colectomy with an Ultrasonic Device. JSLS. 2016 Apr-Jun;20(2):e2016.00010. doi: 10.4293/JSLS.2016.00010. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Set - all subjects in whom the procedure was started.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety Set - all subjects in whom the procedure was started. | Posted | Number | 95% Confidence Interval | percentage of subjects | Intraoperatively |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA v 16 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA v 16.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Schwiers | Ethicon | 513-337-1172 | mschwier@its.jnj.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Houston |
| Texas |
| 77054 |
| United States |
| Ziekenhuis Oost-Limburg, Dept of Surgical Oncology | Genk | 3600 | Belgium |
| The Royal Surrey County Hospital NHS Trust | Guildford | Surrey | GU2 7XX | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Safety Set - all subjects in whom the procedure was started. | Posted | Number | 95% Confidence Interval | percentage of participants | Intraoperatively |
|
|
|
| 5 |
| 40 |
| 20 |
| 40 |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v 16 | Non-systematic Assessment |
|
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA v 16.0 | Non-systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA v 16.0 | Non-systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA v 16.0 | Non-systematic Assessment |
|
| Splenic haematoma | Injury, poisoning and procedural complications | MedDRA v 16.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v 16.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA v 16.0 | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA v 16.0 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v 16.0 | Non-systematic Assessment |
|
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.