The development of a novel self-activating device to improve the nasal deformity for cleft lip/palate patients
Phase 1
Recruiting
- Conditions
- cleft lip and palate
- Registration Number
- JPRN-jRCTs032210533
- Lead Sponsor
- Kobayashi Shinji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety evaluation: <br>Occurrence of skin ulceration up to the first chiloplasty
- Secondary Outcome Measures
Name Time Method