JPRN-jRCTs032210533
Recruiting
Phase 1
An exploratory study to assess safety and effectiveness of a novel self-activating nasal molding device for cleft lip/palate patients with nasal deformity Phase I/II trial
Kobayashi Shinji0 sites10 target enrollmentJanuary 4, 2022
Conditionscleft lip and palate
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- cleft lip and palate
- Sponsor
- Kobayashi Shinji
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Patients with unilateral cleft lip or unilateral incomplete cleft lip and palate whose age at the time of enrollment was between 2 days and less than 3 month of age.
- •(2\) Patients to whom this device can be fitted.
- •(3\)Patients who can provide written consent from their guardian to participate in this study.
- •(4\) In principle, patients who are able to attend the outpatient clinic once a week
Exclusion Criteria
- •(1\) Patients with metal allergies (titanium and stainless steel)
- •(2\) Patients who are judged by a physician to be inappropriate as subjects. For example, if the researcher judges that the guardian is not capable of proper management.
Outcomes
Primary Outcomes
Not specified
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