The development of a novel self-activating device to improve the nasal deformity for cleft lip/palate patients

JRCT ID: jRCTs032210533

Registered date:04/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: cleft lip and palate
• Date of first enrollment: 24/11/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Attaching the nasal device to the nostrils

Outcome(s)

Primary Outcome

Safety evaluation:
Occurrence of skin ulceration up to the first chiloplasty

Secondary Outcome

Validity evaluation
The following items of nasal morphology will be measured using a non-contact scanner.
Length of the base of the nasal wings, height of the nostril margin, width of the nostril margin, angle of the nasal column, height of the nostrils, and width of the nostrils on the affected and healthy sides.
Differences between the left and right sides of the nose and changes before, 4 weeks, at the end of, and 4 weeks after the postoperative observation period.

Efficacy is judged to be present if any of the following are met.
a The height of the affected nostril is greater than 80% of the height of the healthy nostril after the device is installed.
b The width of the nostril margin on the healthy side after the device is placed is greater than 80% of the width of the nostril margin on the affected side.
c The base length of the nasal wing after the device is more than 90% of the base length of the nasal wing before the device.

The rate of home use should be checked in the patient diary.

Key inclusion & exclusion criteria

• Age minimum: >=
• Age maximum: < 3month old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Kobayashi Shinji
• Source(s) of Monetary Support: Kihara Memorial Yokohama Foundation