GATT-Patch vs SURGICEL® for Surgical Bleeding

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: GATT Technologies BV

Must not be taking: Antithrombotics

Disqualifiers: Pregnancy, Infection, Organ transplant, others

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a pre-market, prospective, randomized (1:1), multicenter, pivotal clinical investigation. The purpose of this investigation is to determine the clinical performance of GATT-Patch as compared with SURGICEL® Original for the management of minimal, mild, or moderate bleeding during minimally invasive liver and gallbladder surgery.

Eligibility Criteria

This trial is for adults aged 22 or older needing elective minimally invasive liver or gallbladder surgery. Participants must be able to consent and follow the study's procedures, with a specific type of bleeding during surgery that can't be stopped by usual methods like stitches. Excluded are those with certain blood conditions, severe allergies to product ingredients, pregnant or breastfeeding women, and those on multiple blood-thinning drugs.

Inclusion Criteria

I am 22 years old or older.

Subject is willing and able to give written informed consent for the clinical investigation participation

My surgery will be minimally invasive without using a hand port.

+5 more

Exclusion Criteria

Subject has a known hypersensitivity to brilliant blue (FD&C Blue #1), porcine gelatin

I am scheduled for a specific liver surgery to remove a part of my liver.

I have had or am planning to have an organ transplant.

+15 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Participants undergo minimally invasive liver and gallbladder surgery with either GATT-Patch or SURGICEL® Original for hemostasis

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative drainage volume and complications during hospitalization

Up to 30 days

Follow-up

Participants are monitored for liver resection surface complications and user satisfaction at follow-up visits

6 weeks

1 visit (in-person)

Extended Follow-up

Participants are monitored for any reoperation requirements during a 3-month follow-up period

3 months

Participant Groups

The trial compares GATT-Patch versus SURGICEL® Original in controlling minimal to moderate bleeding during keyhole surgeries on the liver or gallbladder. Patients will randomly receive one of these treatments during their operation to see which one manages bleeding better.

2Treatment groups

Experimental Treatment

Active Control

Group I: GATT-PatchExperimental Treatment1 Intervention

Hemostatic Patch

Group II: SURGICEL® OriginalActive Control1 Intervention

Hemostatic Patch