Clinical Evaluation of LeGoo™ Internal Vessel Occluder Versus Traditional Vessel Loops (LeGoo)
|ClinicalTrials.gov Identifier: NCT00985634|
Recruitment Status : Unknown
Verified September 2009 by Pluromed, Inc..
Recruitment status was: Recruiting
First Posted : September 28, 2009
Last Update Posted : September 28, 2009
|Condition or disease||Intervention/treatment||Phase|
|Off Pump Coronary Artery Bypass Surgery||Device: LeGoo Device: Control||Not Applicable|
The purpose of this study is to evaluate the clinical efficacy of LeGoo™ as compared to a traditional vessel loop. LeGoo is a device that is intended to be used during surgical procedures to temporarily occlude blood vessels while forming an anastomosis. LeGoo™ will be evaluated in subjects undergoing off-pump coronary artery by-pass (OPCAB) surgery. This is a prospective, randomized trial with a 30-day follow-up period. Half of the eligible patients will be randomized to the experimental group (LeGoo™); and the other half to the control group (standard vessel loops).
LeGoo™ is polymer-based device which is comprised of a non-toxic and biocompatible gel that exists as a liquid at low temperatures and rapidly transitions to a solid at body temperature, forming a plug that can occlude blood vessels. LeGoo™ is injected into a blood vessel that is intended to be occluded, where it stays in a "plug" form for several minutes allowing the surgeon to work in a bloodless field. The gel dissolves with time (spontaneously) or can be reversed back to liquid instantly by cooling the site with ice or irrigating with cold saline. Once dissolved below a minimum concentration, the polymer can never re-solidify.
The primary research hypothesis is that surgeons will obtain a bloodless surgical field and achieve satisfactory hemostasis in a larger proportion of anastomoses using LeGoo™ than using a conventional temporary hemostasis technique.
Satisfactory hemostasis is defined by the surgeon who will quantitate his/her observation about the quality of the surgical field using the following scoring system:
- - Excellent hemostasis (no bleeding)
- - Minimal bleeding (bleeding does not interfere with suturing)
- - Modest bleeding (required intermittent use of another device to control bleeding at the site of the anastomosis)
- - Copious bleeding (required continuous use of another device)
"Excellent hemostasis" and "minimal bleeding" are considered "satisfactory hemostasis." Satisfactory hemostasis will constitute a treatment success for the purpose of evaluating the primary efficacy of LeGoo. The primary endpoint is the proportion of anastomoses in which satisfactory hemostasis is achieved.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Clinical Evaluation of LeGoo™ Internal Vessel Occluder Vs Traditional Vessel Loops|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||March 2010|
|Estimated Study Completion Date :||March 2010|
Subjects in this arm, which is assigned at random, will receive the study device.
LeGoo internal vessel occluder. Usage (dose) as required and determined by surgeon.
Active Comparator: Control
Subjects in this arm will not receive the study device, but receive the standard of care for vessel occlusion (vessel loops.)
- The primary research hypothesis is that surgeons will obtain a bloodless surgical field and achieve satisfactory hemostasis in a larger proportion of anastomoses using LeGoo™ than using a conventional temporary hemostasis technique. [ Time Frame: in operating room ]
- Total duration of the anastomosis, blood loss during the surgery, Time required to occlude the vessel, the number of units of blood transfused during hospitalization. [ Time Frame: in operating room (day of surgery) ]
- Safety will be measured by comparing a composite of four serious adverse events experienced by the treated and control groups: death, graft occlusion, myocardial damage, and low post procedure cardiac output. [ Time Frame: one month post op ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985634
|Contact: James A Wilkie, BS||781 932 email@example.com|
|Contact: Jean-Marie Vogel, BS||781 932 firstname.lastname@example.org|
|Klinik fur Herzchirurgie Herzzentrum Leipzig||Recruiting|
|Contact: Ardawan Rastan, MD 49 341 865-1421 email@example.com|
|Principal Investigator: Ardawan Rastan, MD|