JPRN-jRCTs031220604
Recruiting
Phase 1
Clinical study on safety and efficacy of fibroblast growth factor administration to nasal septal perforation
Otori Nobuyoshi0 sites10 target enrollmentFebruary 1, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Otori Nobuyoshi
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Persons with perforation of the nasal septum visible by nasal fiberscope.
- •2\)Those with nasal septal perforation for at least six months
- •3\)Age at the time of obtaining consent is at least 20 years
- •4\)Persons who have given their free and written consent
Exclusion Criteria
- •1\) Patients with serious hepatic, renal, or circulatory disorders
- •2\) Patients with malignant tumors
- •3\) Patients with a history of serious drug allergy or serious adverse drug reactions such as anaphylactic shock, those with a history of allergy to gelatin, and those allergic to anesthetics
- •4\) Patients who have participated in a clinical trial and taken an investigational drug within 4 weeks prior to obtaining consent
- •5\) Patients who are scheduled to undergo surgical treatment between the time consent is obtained and the end of the study period
- •6\) Patients who are pregnant or may become pregnant
- •7\) Patients who are breast\-feeding
- •8\) Patients who have uncontrolled diabetes mellitus
- •9\) Patients with poorly controlled sinusitis or allergic rhinitis
- •10\) Patients at high risk of bleeding who are taking anticoagulants or antiplatelet agents
Outcomes
Primary Outcomes
Not specified
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