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NCT01759550 · ClinicalTrials.gov registry record
Prospective Case-Series of Ligasure Advance Pistol Grip and LigaSure Blunt Tip
A clinical trial, sponsored by Duke University.
- Terminated
- Registry status
- 51
- Enrollment target
NCT01759550 is a clinical trial that was terminated before completion, run by Duke University. The registered enrollment target is 51 participants.
The verdict
NCT01759550 was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- 51 participants
- Enrollment target
Study 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01759550
The ClinicalTrials.gov registry entry for NCT01759550 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01759550 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01759550 about?
NCT01759550 is a clinical study titled "Prospective Case-Series of Ligasure Advance Pistol Grip and LigaSure Blunt Tip". 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 ...
What is the current status of trial NCT01759550?
This trial is currently terminated. The enrollment target is 51 participants. The study started on 2011-09. Estimated completion is 2014-06.
Who is sponsoring clinical trial NCT01759550?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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