A Prospective, Multicenter, Randomized Clinical Investigation Evaluating GATT-Patch for Hemostasis during Minimally Invasive Liver and Gallbladder Surgery

Clinical Trial Details

This study is evaluating an investigational device (also known as the “study device”) called GATT-Patch as a possible management of minimal to moderate bleeding during liver surgery. An investigational device is one that has not been approved by the United States (US) Food and Drug Administration (FDA).

GATT-Patch is a small, flexible piece of gelatin that contains a man-made substance. When the patch comes into contact with tissue and blood, it adheres to the tissue and encourages the blood to clot and stop or reduce blood loss. Previous animal and human studies suggest that GATT-Patch does this more quickly and effectively than current patches used in liver or gallbladder surgery. Based on previous testing, GATT-Patch is also believed to dissolve within 4-6 weeks, faster than patches currently used in surgery.

Participants will be randomized to receive either the GATT-Patch or Surgicel Original. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

Participation will entail two follow-up visits post-surgery.

Key Eligibility:

Inclusion Criteria:

Scheduled to undergo elective minimally invasive (robotic or laparoscopic) surgery on the liver, including cholecystectomy
22 years of age or older at the time of enrollment

Exclusion Criteria:

Scheduled to undergo surgery on organs other than the liver and its associated biliary and vascular system
Participants who are pregnant, planning on becoming pregnant or actively breastfeeding during the 3-month follow-up period
Participant who has religious objections to receiving products containing porcine
Currently participating or has participated in another clinical investigation within the past 30 days that may affect the endpoints of the study, such as trials related to the surgical procedure and anti-coagulation

Detailed eligibility will be discussed when reaching out to the study team.

Return to List