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Clinical Trials/JPRN-jRCTs032210533
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

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.

Registry
who.int
Start Date
January 4, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Kobayashi Shinji

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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