NCT06696092

Safety and Efficacy of WoundClot Surgical

A Single Arm, Open Label, Multi-Center Study Evaluating the Efficacy and Safety of WoundClot Surgical

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Core Scientific Creations Ltd. · Industry
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to verify that WoundClot Surgical helps stop bleedings which may occur during surgery. It will also help learn more about the safety of WoundClot Surgical. The main questions this clinical trial aims to answer are: What is the rate at which WoundClot Surgical helps resolve bleeding after it is applied to a site of a bleeding during surgery? How long does it take from the moment WoundClot Surgical is applied to a site of a bleeding during surgery until the bleeding is resolved? What medical problems do participants have if WoundClot Surgical is applied to a site of a bleeding during surgery? There is a single treatment group in this study and, if a participant is enrolled (ie, gives consent to participate, meets all conditions for study entry, and experiences a bleeding during the surgery), WoundClot Surgical will be applied to the site of bleeding. The enrolled participants will also need to visit the clinic 8 weeks (± 3 days) after the surgery for checkups.

Detailed description

Following provision of consent, the prospective subjects will be screened for eligibility to participate in the study (Visit 1). Screening procedures and evaluations will include laboratory analyses of complete blood count, serum chemistry, coagulation parameters, and a pregnancy test. Medical history and concomitant medications will be recorded. A physical examination will be conducted, and vital signs will be taken. Once initial eligibility is confirmed, subjects will be scheduled for the procedure for which they are indicated (Visit 2). If the intra-operative eligibility criteria are fulfilled, WoundClot Surgical will be used (study intervention). Time to hemostasis and any additional surgical and non-surgical intervention(s) or reintervention(s), for persistent or recurrent bleeding, respectively, will be recorded. Two follow-up visits will be conducted, as part of the planned protocol procedures - on the day after the procedure (Visit 3; if the subject is released from the facility on the same day, this Visit will be conducted prior to the release) and 8 weeks ± 3 days after the procedure (Visit 4; last study Visit). Any additional intervention(s) or reintervention(s) for recurrent bleeding and complications of the initial intervention, whether deemed related to the study intervention (device and/or procedure) or not, will be recorded during every study Visit, planned or unscheduled, starting after Visit 2. Administration of blood products at any time after the study intervention and before end of study will be captured. Any device deficiencies and any adverse events, whether deemed related to the study device and/or procedure or not, will be recorded at every study Visit, planned or unscheduled.

Conditions

• Surgical Bleeding

Interventions

Type	Name	Description
DEVICE	Hemostatic Agent	WoundClot Surgical may be used in a single target bleeding site of each subject.

Timeline

• Start date: 2024-10-02
• Primary completion: 2025-03-13
• Completion: 2025-05-08
• First posted: 2024-11-20
• Last updated: 2025-06-26

Locations

8 sites across 1 country: Romania