A Phase 2/3 interventional study of MICE and SPA ligation in Epistaxis, sponsored by University of Calgary. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-06-12.
Sponsored by University of Calgary · Phase 2/3, Interventional, and Treatment
Epistaxis is a common disorder with 60% of the population suffering from one episode and 10% of these cases requiring medical attention. Between March 2006 and March 2007, in Calgary, Alberta, there were 1500 presentations of epistaxis to adult emergency rooms with 7% of these (105 patients) requiring packing with admission. Common methods to control epistaxis include, nasal packing (88%), operative arterial ligation (10%), and arterial embolization (2%). A cost analysis demonstrated that nasal packing had a lower cost compared to embolization and arterial ligation, and all modalities had similar lengths of stay (Goddard, Otolaryng Head Neck Surg. 2006). Arterial ligation is the current recommended therapy for recurrent or refractory epistaxis, with a success rate of 98%. With the advancement of endoscopic techniques, emergency room Minimally Invasive Control of Epistaxis (M.I.C.E.) allows for selective packing and cauterization, which provides the patient with retained function of their nasal cavity and prevents a hospital admission, resulting in significant cost savings.
Hypothesis:
Does the M.I.C.E. procedure provide significant cost savings compared to operative sphenopalatine artery ligation? Null hypothesis is that there is no difference in hospital admission rates between M.I.C.E. and operative sphenopalatine artery ligation.
93 studies on the registry are indexed under Epistaxis; 21 are open to participants now.
This study's enrollment of 3 is below the median of 60 across 77 interventional studies indexed under Epistaxis.
Browse Epistaxis studies →University of Calgary is the lead sponsor of 699 studies on the registry; 192 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
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Refractory or Recurrent Epistaxis defined as:
Exclusion Criteria:
MICE
Procedure: MICE
SPA ligation
Procedure: SPA ligation
MICE
SPA ligation
Change in hospital admission requirement between M.I.C.E. and Operative Sphenopalatine Ligation
Time frame: 30 days
The record gives a start of Jun 2008, a primary completion of Jun 2009 and a completion of Jun 2009. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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