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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032210533

Enrollment

Registered

2022-01-04

Start date

2022-11-24

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

cleft lip and palate

Interventions

Attaching the nasal device to the nostrils

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Safety evaluation: Occurrence of skin ulceration up to the first chiloplasty	—

Secondary

Measure	Time frame
Validity evaluation The following items of nasal morphology will be mea sured using a non-contact 3D camera/scanner. Length of the base of the nasal wings, height of the nostril margin, width of the nostril margin, angle of t he 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 n ose and changes before, 4 weeks, at the end of, and 4 weeks to one year after the postoperative obs ervation period. Efficacy is judged to be present if any of the followi ng are met. a The height of the affected nostril is greater than 8 0% of the height of the healthy nostril after the devi ce is installed. b The width of the nostril margin on the healthy side after the device is placed is greater than 80% o f 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 pati ent diary.	—

Measure

Time frame

Validity evaluation The following items of nasal morphology will be mea sured using a non-contact 3D camera/scanner. Length of the base of the nasal wings, height of the nostril margin, width of the nostril margin, angle of t he 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 n ose and changes before, 4 weeks, at the end of, and 4 weeks to one year after the postoperative obs ervation period. Efficacy is judged to be present if any of the followi ng are met. a The height of the affected nostril is greater than 8 0% of the height of the healthy nostril after the devi ce is installed. b The width of the nostril margin on the healthy side after the device is placed is greater than 80% o f 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 pati ent diary.

—

Contacts

Public ContactMakiko Takahashi

Clinical Research Institute, Kanagawa Children`s Medical Center

r_kenkyu1@kcmc.jp+81-45-711-2351

Outcome results

None listed

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