Efficacy Study to Evaluate Laparoscopic Fascial Closure Device
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ClinicalTrials.gov Identifier: NCT01024296 |
Recruitment Status
:
Completed
First Posted
: December 2, 2009
Results First Posted
: October 12, 2017
Last Update Posted
: October 12, 2017
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Tracking Information | ||||
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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 |
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Original Primary Outcome Measures ICMJE |
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 |
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). |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hernia, Abdominal | |||
Intervention ICMJE | Device: Port Close
Device for applying loop suture to close surgical site |
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Study Arms | Experimental: Gastric Bypass Surgery Patients
Surgical site closure using Port Close device
Intervention: Device: Port Close |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
4 | |||
Original Estimated Enrollment ICMJE |
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
Exclusion Criteria:Vulnerable subjects will be excluded including:
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Sex/Gender |
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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 ) |
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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 |
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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 |