Efficacy Study to Evaluate Laparoscopic Fascial Closure Device

Tracking Information
First Submitted Date ICMJE	November 13, 2009
First Posted Date ICMJE	December 2, 2009
Results First Submitted Date	September 15, 2017
Results First Posted Date	October 12, 2017
Last Update Posted Date	October 12, 2017
Actual Study Start Date ICMJE	July 2009
Actual Primary Completion Date	March 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 15, 2017)	Count of Participants With Successful Port Site Closure Using Port Close Device [ Time Frame: Day 1, at the end of surgery ]; Time of Port Site Closure [ Time Frame: Day 1, from insertion to removal of Port Close device during surgery ]
Original Primary Outcome Measures ICMJE; (submitted: November 30, 2009)	Closure of Port Site [ Time Frame: 1 Day ]
Change History	Complete list of historical versions of study NCT01024296 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE; (submitted: November 30, 2009)	Safety of closure device [ Time Frame: 1 day ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Efficacy Study to Evaluate Laparoscopic Fascial Closure Device
Official Title ICMJE	Pivotal Study to Evaluate the Efficacy of a Laparoscopic Port Closure Device
Brief Summary	During any minimally invasive surgery case, 5-25mm size incisions need to be made to gain access to the abdomen. One of the most difficult, time-consuming, and sometimes unreliable parts of the case is closing these incisions, especially in obese patients. This is mainly because these incisions are very small and the layer that needs to be closed (fascia) rests deep underneath the skin and fat tissue of the abdominal wall. Two of the investigators (CM and BS) have developed at Stanford an instrument that allows for an easier and more reliable closure of these wounds. The purpose of this study is to test this instrument in the closure of laparoscopic wounds in obese patients undergoing laparoscopic gastric bypass surgery.
Detailed Description	For the patients enrolling in this study, preoperative and postoperative care will be exactly the same. The operative procedure will also be very similar with the only modification being in the way the ports are closed at the end of the surgery and the fact that all ports 11mm or greater will be closed (instead of leaving 11 or 12mm ports to be closed at the discretion of the surgeon). Instead of using a suture-passer to place the suture through the fascia, the surgeon will use the new instrument to drive the suture into the tissue under direct visualization through the umbilical port camera. The same instrument but with new sutures will be used for each of the interrupted stitches that are usually placed to close the port. The instrument that has been developed by some of the investigators is a 10mm elongated device that can easily be inserted into the port or fascial opening. If inserted through the port, the trocar can then be slid over the instrument to remove the trocar without losing pneumoperitoneum. The instrument has two opposing wings that will open once placed beyond the fascial opening. As the surgeon pulls up on the device, the wings open sliding along the fascia and pushing away any intra-abdominal contents that may be close to the instrument. Once the surgeon assures under direct visualization with the camera that the wings are open at both sides of the wound and that all intra-abdominal contents are out of the way (just as the surgeon would with the standard technique), he or she pushes a plunger that drives two flexible nitinol needles from the shaft of the instrument, through the fascia, and into the wings. The needles will be received in the wings by a set of couplers attached to the same suture that would be used otherwise (#0 Vycril). The surgeon then releases the wings and pulls out the device, leaving a looped suture placed around the opening. The surgeon can then tie the sutures as he or she would normally do on the standard procedure. At any time, the surgeon can reposition or remove the instrument without placing the sutures. The procedure may be repeated as many times as the surgeon considers necessary (usually 1 to close the 11 or 12mm fascial ports and 2 or 3 to close the 25mm fascial port).
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Hernia, Abdominal
Intervention ICMJE	Device: Port Close; Device for applying loop suture to close surgical site
Study Arms	Experimental: Gastric Bypass Surgery Patients; Surgical site closure using Port Close device; Intervention: Device: Port Close
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 15, 2017)	4
Original Estimated Enrollment ICMJE; (submitted: November 30, 2009)	5
Actual Study Completion Date	March 2010
Actual Primary Completion Date	March 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria:- Clinical Diagnosis of Morbid Obesity; BMI > 40 or BMI > 35 with medical comorbidities; Undergoing laparoscopic gastric surgery; Have at least one trocar site measuring 12 mm or greater Exclusion Criteria:Vulnerable subjects will be excluded including: Children; Pregnant women; Economically and educationally disadvantaged; Decisionally impaired; Homeless people; Employees and students.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01024296
Other Study ID Numbers ICMJE	SU-11062009-4361; IRB Protocol #8864 ( Other Identifier: Stanford University )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Thomas Krummel, Stanford University
Study Sponsor ICMJE	Stanford University
Collaborators ICMJE	SurgSolutions, LLC
Investigators ICMJE	Principal Investigator: Thomas M. Krummel Stanford University
PRS Account	Stanford University
Verification Date	September 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP