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 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT06696092
Eligibility Criteria:
Inclusion Criteria:
1. Pediatric, including newborn (from birth to 1 month of age), or adult (aged 80 or below) patient.
2. Undergoing elective (non-emergency), open or laparoscopic soft tissue dissection, vascular, spinal, thyroid, breast, or gastrointestinal surgery, or hepatic resection.
NOTE: for this study, soft tissue dissection may be part of:
abdominoplasty, lower anterior resections, abdominal perineal resection, distal pancreatectomy, esophagectomy, skin graft donor site in burn patients, and mastectomy.
3. Indicated for use of topical mechanical hemostat due to mild to moderate bleeding.
4. Has not received transfusion of blood or blood products between screening and study intervention.
5. Has a target bleeding site that is identifiable and has an approximate surface area of less than or equal to 100 cm\^2.
6. Has last pre-study-intervention hematology and biochemistry values within the following limits:
1. hemoglobin ≥ 8 g/dL (g/100 mL)
2. platelets ≥ 150 x 10\^9/L (x 10\^3/mm\^3)
3. white blood cells (WBC) ≥ 3.0 x 10\^9/L (x 10\^3/mm\^3)
4. absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (x 10\^/mm\^)
5. serum creatinine \< 1.5 mg/dL
6. aspartate aminotransferase (AST) \< 1.5 x ULN (upper limit of norm)
7. alanine aminotransferase (ALT) \< 1.5 x ULN
8. alkaline phosphatase (ALP) \< 1.5 x ULN
7. Willing and able to return for the required follow-up visits following study enrollment.
8. If able to reproduce, agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits when engaging in heterosexual intercourse.
9. Signed informed consent.
Exclusion Criteria:
1. If female and of child-bearing potential, has positive pregnancy test during screening and/or is breast-feeding.
2. Participation in another interventional study.
3. Febrile illness within 7 days of study intervention.
4. History of coagulopathy or intra-procedural coagulopathy prior to study intervention.
5. Intra-operative complications requiring resuscitation.
6. Radiofrequency coagulation, other than focal radiofrequency ablation of vessels, of the target bleeding site prior to study intervention.
7. Application of topical hemostat to the target bleeding site prior to study intervention.
8. Known hypersensitivity to carboxymethyl cellulose or compounds containing it or its salts.
9. In patients undergoing vascular surgery where heparin use is required, history of heparin-induced thrombocytopenia.
10. Prisoners.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
80 Years
Study:
NCT06696092
Study Brief:
Protocol Section:
NCT06696092