Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT04455035
Eligibility Criteria:
Inclusion Criteria:
Retrospective Group:
* Unilateral cleft lip with or without cleft palate
* Patients of a single surgeon (Matthew Greives, MD)
* Patients with complete photographs:
* After birth, first visit
* At cleft lip repair (3-4 months)
* Post-operative cleft repair (about 1 year of age)
Prospective Group:
* Patients with incomplete unilateral cleft lip with or without cleft palate
* Patients of any surgeon
Exclusion Criteria:
Retrospective Group:
* Bilateral cleft lip or complete unilateral cleft lip
* Patients operated on by other primary surgeons
* Patients with incomplete photo records will be evaluated to determine if the patient should be excluded
Prospective Group:
* Patients with bilateral cleft lip or complete unilateral cleft lip
* Patients whose parents refuse to consent to inclusion
* Patients with tape allergies to the adhesive of the DynaCleft®
* Patients with syndromic craniofacial conditions or Tessier type facial clefts
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
6 Months
Study:
NCT04455035
Study Brief:
Protocol Section:
NCT04455035