Clinical research on an off-label use of implant-type tissue-engineered cartilage

Clinical research on an off-label use of implant-type tissue-engineered cartilage - Off-label use of tissue-engineered cartilage

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028351

Enrollment

Registered

2017-07-24

Start date

2017-07-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholesteatoma

Interventions

Use of implant-type tissue-engineered cartilage for reconstruction of external auditory canal in otologic surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cholesteatoma with indication for surgery (moderate or severe case)

Exclusion criteria

Exclusion criteria: 1. Post-operative ear 2. infection with MRSA, Pseudomonas with multiple drug resistances, etc. 3. Continuous purulent discharge (otorrhea) 4. When anticoagulant drugs cannot be discontinued 5. Diabetes mellitus with poor control 6. Severe disorder in circulatory, respiratory, hepatic, renal, or hematologic organs 7. Severe allergic disease 8. inability to use post-operative antibiotics because of drug allergy 9. Malignant disease in internal organs, blood, etc. 10. Addict of narcotic drugs, alcohol, etc. etc.

Design outcomes

Primary

Measure	Time frame
Retraction of external auditory canal evaluated by CT at 6-months after surgery, compared to the state at 3-months after surgery.	—

Countries

Japan

Contacts

Public ContactKen ITO

Teikyo University Hospital Otolaryngology

orl@med.teikyo-u.ac.jp03-3964-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026