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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT01701193
Eligibility Criteria:
Inclusion Criteria:
* Subjects are female
* Subjects are 18 years of age or older at the time of consent
* Subjects have a BMI between 17-40
* Subjects must have signed informed consent form
* Subjects have a preoperative diagnosis of uterine fibroids and plan to have a myomectomy completed surgically as part of their standard of care
* Subjects must have a physical examination and compliance assessment
Exclusion Criteria:
* Subjects whose BMI is outside the range of 17-40
* Subjects participating in another clinical trial with a drug or device
* Subjects who have participated in a clinical trial with a drug or device within 30 days prior to this study
* Subjects with suspected or diagnosed pregnancy
* Subjects with suspected intraabdominal infection
* Subjects who are immunocompromised
* Subjects diagnosed with cancer
* Subjects treated with hemostatic agents (e.g. fibrin sealant, collagen, oxidized cellulose)
* Subjects treated with adhesion prevention agents other than the Anti-Adhesion product (APP) (e.g. Intergel ® Adhesion Prevention Solution, Seprafilm ® Membrane)
* Subjects taking anti-epileptic medication
* Subjects who have been treated with Methotrexate or other chemotherapeutics agents
* Subjects with an American Fertility Society score of Stage D at the time of myomectomy as determined by the surgeon
* Positive viral serology screening results for hepatitis B surface antigen, antibodies to hepatitis C virus or human immunodeficiency
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01701193
Study Brief:
Protocol Section:
NCT01701193