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:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT06522958
Eligibility Criteria:
Inclusion Criteria:
* Patients ages 0 years, 6 months to 18 years of age
* Patients with a diagnosed cleft/craniofacial condition undergoing one of the following cleft/craniofacial related surgeries in the upcoming calendar year (a-c):
1. Cleft Palate Repair (Palatoplasty)
2. Alveolar Bone Graft Surgery
3. Velopharyngeal Insufficiency Surgery
* Patients who eat fully by mouth (PO)
* Patients who adhered to scheduling protocols and attended all necessary pre- and post-operative visits
Exclusion Criteria:
* Patients under the age of 6 months or over the age of 18
* Patients who utilize an NG-tube or G-tube for primary means of nutrition/hydration
* Patients who have PO recommendations from a licensed Speech-Language Pathologist that prevents their ability to consume Level 4 IDDSI (pureed) foods, including patients who are NPO.
* Patients with any diagnosed allergies to the ingredients listed on the Savorease Therapeutic Foods ingredient labels
* Patients/caregivers who are not able to participate in pre- and post-operative protocoled visits for any reason
* Patients/caregivers who are not able to respond to written questions presented in English
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
18 Years
Study:
NCT06522958
Study Brief:
Protocol Section:
NCT06522958