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 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT07148895
Eligibility Criteria:
Inclusion Criteria:
* Children aged 18 and younger
* Diagnosis of a \<3cm midline neck mass, tract or sinus as determined by preoperative physical examination and imaging
* Patient scheduled for Sistrunk procedure (excision of TGDC)
* Patient assigned to the drain or no drain groups at the time of surgery.
* Sistrunk procedure performed per best practices and standardized per surgical study protocol.
* Patient admitted for overnight observation.
* Thyroglossal duct cyst confirmed on final pathology.
Exclusion Criteria:
* Patients with confirmed bleeding or immunodeficiency disorders as previously documented in electronic medical record.
* Lesions greater than 3cm on preoperative ultrasound or axial imaging
* Lingually positioned lesions.
* Evidence of overt infection at the time of surgery
* Coexistent lesion excision (e.g., branchial cleft cyst excision, thyroidectomy)
* Entry into oropharynx noted during procedure.
* Revision surgery if prior formal Sistrunk performed.
* Patients in whom the surgeon deems a drain is necessary.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
17 Years
Study:
NCT07148895
Study Brief:
Protocol Section:
NCT07148895