A Single Center, Prospective, Open-Label, Single-Arm Study To Evaluate The Safety And Efficacy Of The Resolv® Endoscopic Hemostat System In Achieving Acute Hemostasis In Adult Subjects Diagnosed With Non-Variceal Upper Gastrointestinal Bleeding.

Gastrointestinal bleeding (GIB) is a common clinical problem.  Upper GI bleeding as defined by bleeding proximal to the ligament of Trietz is estimated in 47/100,000 population.  Thirty-day mortality of up to 10% has been reported.  Endoscopic therapies performed within 24 hours after onset of GIB has shown to be effective in controlling the bleeding and need for surgery and hence is generally recommended.

While there have been advances in endoscopic hemostasis, there has also been an increased use of novel anticoagulants and anti-platelet agents which increase the risk of bleeding.  Also, advances in endoscopic interventions such as endoscopic mucosal resection and dissection have become the standard of care.  These procedures have also increased the risk of bleeding.  Endoscopic spray therapies have recently been used and provide hemostasis in situations where bleeding site is difficult to access, control of bleeding is not achieved despite standard therapies, or when there is diffuse bleeding from a tumor or endoscopic intervention site.  Endoscopic spray for hemostasis is also easy where technical expertise is lacking.

Spray based endoscopic therapies for hemostasis have been used successfully.  When sprayed the inert compound absorbs water and causes mechanical tamponade by binding cohesively and adhesively.  These compounds enhance clot formation and typically the coagulum sloughs off in 24-72 hours revealing a clean nonbleeding lesion when reassessed endoscopically.  Safety and efficacy of these substances was established and spray based hemostasis is now used either as a primary or adjunct therapy for hemostasis.  A recent retrospectively done study matching a polysaccharide based endoscopic spray therapy with conventional therapy, showed equal efficacy of spray agent for both immediate hemostasis and reduction of re-bleeding.

This study will evaluate the safety and efficacy of the Resolv Endoscopic Hemostat System in achieving acute hemostasis in adult subjects diagnosed with non-variceal upper gastrointestinal bleeding.  The study period is from the time of the index procedure and Resolv Endoscopic Hemostat application (Timepoint day 0) up to 30 days (+/- 3 days) following the date of the hemostat application.