Efficacy Study to Evaluate Laparoscopic Fascial Closure Device
Pivotal Study to Evaluate the Efficacy of a Laparoscopic Port Closure Device
2 other identifiers
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 13, 2009
CompletedFirst Posted
Study publicly available on registry
December 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
October 12, 2017
CompletedOctober 12, 2017
September 1, 2017
8 months
November 13, 2009
September 15, 2017
September 15, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Count of Participants With Successful Port Site Closure Using Port Close Device
Day 1, at the end of surgery
Time of Port Site Closure
Day 1, from insertion to removal of Port Close device during surgery
Study Arms (1)
Gastric Bypass Surgery Patients
EXPERIMENTALSurgical site closure using Port Close device
Interventions
Device for applying loop suture to close surgical site
Eligibility Criteria
You may qualify if:
- BMI \> 40 or BMI \> 35 with medical comorbidities
- Undergoing laparoscopic gastric surgery
You may not qualify if:
- Children
- Pregnant women
- Economically and educationally disadvantaged
- Decisionally impaired
- Homeless people
- Employees and students.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- SurgSolutions, LLCcollaborator
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bilal M Shafi, MD
- Organization
- Stanford University
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas M. Krummel
Stanford University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
November 13, 2009
First Posted
December 2, 2009
Study Start
July 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
October 12, 2017
Results First Posted
October 12, 2017
Record last verified: 2017-09