Clinical study on fibroblast growth factor administration to nasal septal perforatio

Phase 1

Recruiting

• Conditions: nasal septal perforation; Nose Diseases; D061270

• Registration Number: JPRN-jRCTs031220604
• Lead Sponsor: Otori Nobuyoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

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
11) Patients who are easily infected by autoimmune diseases, acquired immunodeficiency syndrome, taking immunosuppressive drugs
12) Other subjects who are deemed inappropriate to participate in this research by the principal investigator (subinvestigator)

Study & Design

• Study Type: Interventional
• Study Design: Not specified