Last updated: August 25, 2023
Sponsor: University Hospital, Toulouse
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
endoscopic ligation
Supra-selective embolization
Clinical Study ID
NCT05281952
RC31/19-0550
2020-A02824-35
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient with severe epistaxis who failed treatment with double tamponade for more than 48 hours.
- Patient over 18 years old
- Affiliated patient or beneficiary of a social security scheme.
- Patient accepting the principle of randomization
- Free, informed and written consent, signed by the participant and the investigator (atthe latest on the day of inclusion and before any examination required by theresearch).
Exclusion
Exclusion Criteria:
- Patient with epistaxis secondary to facial and/or surgical trauma.
- Patient with epistaxis related to a malignant tumor cause
- Patient with a history of ligation or embolization
- Patient under legal protection and/or curatorship and/or guardianship.
- Impossibility of giving the person informed information and ensuring the subject'scompliance due to impaired physical and/or psychological health.
- Patient participating in another research including an exclusion period still inprogress
- Pregnant or breastfeeding patient For non randomized patient
- Patient with a contraindication to general anesthesia: severe and/or decompensatedcardiac/hepatic/renal insufficiency, ASA score 4
- Severe hemostasis disorders that cannot benefit from correction.
- History of transient and/or definitive stroke of the ischemic type
- Atheromatous overload
Study Design
Total Participants: 180
Treatment Group(s): 2
Primary Treatment: endoscopic ligation
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
December 31, 2026
Study Description
Connect with a study center
University Hospital
Toulouse,
FranceActive - Recruiting
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