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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT05103956
Eligibility Criteria:
Inclusion Criteria:
* Patients of legal age.
* Indication of total thyroidectomy due to multinodular goiter.
* Accept to enter the study and sign the informed consent.
* Patient willing and able to complete clinical trial procedures, as described described in the protocol.
Exclusion Criteria:
* Patients under 18 years of age.
* Patients with surgical indication for hemithyroidectomy or subtotal thyroidectomy (eg unilateral nodular goiters).
* Multinodular goiter with high suspicion or preoperative diagnosis of cancer (Bethesda V and VI and / or infiltration of neighboring structures on imaging tests).
* Known allergy or hypersensitivity to a component of the Hemopatch® investigational treatments, riboflavin, or bovine proteins.
* Concurrent or prior therapy with systemic pharmacological agents that promote blood clotting, including, but not limited to, tranexamic acid, activated factor VII, fibrinogen, and aprotinin.
* Pregnancy or breastfeeding.
* Refuse to enter the study and sign the informed consent.
* Not agreeing to carry out all the planned follow-up.
* Concurrent participation in another clinical trial with a medical device or drug or with interfering endpoints Inability to understand the nature and scope of the trial and the required procedures.
Criteria to be verified during surgery (Intraoperative exclusion criteria):
* Persistent major bleeding after primary hemostasis.
* Infection of the surgical area.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05103956
Study Brief:
Protocol Section:
NCT05103956