Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-02-25 @ 7:22 PM
Study NCT ID:
NCT01759550
Status:
TERMINATED
Last Update Posted:
2024-01-17
First Post:
2012-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Case-Series of Ligasure Advance Pistol Grip and LigaSure Blunt Tip
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Prospective Case-Series of LigaSure Advance Pistol Grip and LigaSure Blunt Tip in Gastric Procedures
Status:
TERMINATED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The Sponsor terminated the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is primarily to evaluate the safety and efficacy of the LigaSure Advance™ Pistol Grip and LigaSure™ Blunt Tip using the Force Triad™ Energy Platform during Roux-en-Y and gastric reduction procedures (sleeve gastrectomy or placation), respectively. Also, Economic value of using LigaSure in gastric surgeries will be appraised.
In this prospective case series, 60 patients previously scheduled to undergo a Roux-en-Y or gastric reduction procedure (sleeve gastrectomy or placation) will have hemostasis controlled with LigaSure Advance ™ Pistol Grip or LigaSure™ Blunt Tip, respectively. All subjects undergoing Roux-en-Y or gastric reduction procedures (sleeve gastrectomy or placation) procedure at Durham Regional Hospital will be recruited.
Data Analysis will be performed using the data collected in the software program titled MetaBar at Duke University Medical Center. Categorical variables will be summarized as proportions for each category; continuous measures will be summarized by mean and standard deviation or median and range as appropriated for the data distribution. Procedure-related risks are those typically associated with gastric procedures and general anesthesia including intra-operative bleeding, infection, and injury to surrounding organs and structures. Device related risks include those normally associated with the use of electrosurgery including intra-operative bleeding, unintended tissue burns, electrical shock, and electrical stimulation of muscles and nerves.
In this prospective case series, 60 patients previously scheduled to undergo a Roux-en-Y or gastric reduction procedure (sleeve gastrectomy or placation) will have hemostasis controlled with LigaSure Advance ™ Pistol Grip or LigaSure™ Blunt Tip, respectively. All subjects undergoing Roux-en-Y or gastric reduction procedures (sleeve gastrectomy or placation) procedure at Durham Regional Hospital will be recruited.
Data Analysis will be performed using the data collected in the software program titled MetaBar at Duke University Medical Center. Categorical variables will be summarized as proportions for each category; continuous measures will be summarized by mean and standard deviation or median and range as appropriated for the data distribution. Procedure-related risks are those typically associated with gastric procedures and general anesthesia including intra-operative bleeding, infection, and injury to surrounding organs and structures. Device related risks include those normally associated with the use of electrosurgery including intra-operative bleeding, unintended tissue burns, electrical shock, and electrical stimulation of muscles and nerves.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: