SBIR-STTR Award

Non-variceal upper gastrointestinal bleeding (NVUGIB) is a major cause of morbidity and mortality worldwide. Incidence of NVUGIB in the US is 53 events per 100,000 adults, with approximately 160,000 hospital admissions annually. US treatment and prevention of NVUGIB continues to be a major medical emergency, costing 550-900 million dollars every year. Failure in standard of care for NVUGIB results in mortality rates from 3-4% in the US. An improved hemostatic approach to NVUGIB will significantly reduce hemorrhage related morbidity and mortality with substantial follow-on benefits to patient comfort and reduced cost in hospital care. An ideal device would be nontoxic, provide immediate hemostasis, would not require significant follow-up or removal, and allow low accuracy/acuity placement. This proposal addresses the development of such a device. To address serious NVUGIB, HemCon proposes to develop a chitosan gastrointestinal hemostatic dressing (CGHD) suitable for use in the unique environment of the gastro-intestinal (GI) tract with rapid delivery by endoscopy. The primary objective of this research proposal is to demonstrate feasibility of development of a novel efficacious CGHD and its management of challenging acute GI bleeding in a low pH fluid (i.e. the gastric environment) that can be left in place to be digested or dissolved in less than 168 hours. A secondary objective is to develop the CGHD so that it is compatible with a diagnostic endoscope via an anticipated umbrella catheter delivery system. The central hypothesis of this proposal is that the CGHD will provide effective immediate and sustained hemostasis for brisk non-variceal upper GI bleeding.

Public Health Relevance Statement:


Public Health Relevance:
The chitosan gastrointestinal hemostatic dressing (CGHD) development will provide for rapid control (d 1 hour) of robust gastrointestinal bleeding under hospital care enabling significant reduction in morbidity and mortality (currently 3-4%) associated with non- variceal upper gastrointestinal bleeding (NVUGIB). The CGHD development has the potential to significantly reduce the overall length and cost of hospitalization associated with NVUGIB by hundreds of millions of dollars.

Project Terms:
Acute; Address; Adherence (attribute); Adhesions; Admission activity; Adult; biomaterial compatibility; Caring; Catheters; Cauterization - action; Chitosan; Clinical Trials; Clip; cohesion; cost; cytotoxicity; Deacetylation; Defect; Development; Devices; Diagnostic; Drug Formulations; Emergency Situation; Endoscopes; Endoscopy; Environment; Epinephrine; Event; Excision; Failure (biologic function); Family suidae; follow-up; gastrointestinal; Health Care Costs; Hemorrhage; Hemostatic Agents; Hemostatic function; high risk; Hospitalization; Hospitals; Hour; improved; In Vitro; in vitro testing; in vivo; Incidence; Injection of therapeutic agent; Interventional radiology; Intestines; Left; Length; Liquid substance; Mechanics; Medical; Methods; Modality; Modeling; Modification; Morbidity - disease rate; Mortality Vital Statistics; Nitrogen; novel; Operative Surgical Procedures; Particulate; Patients; Pharmacologic Substance; Physicians; Prevention; prototype; public health relevance; Research Proposals; screening; seal; Simulate; Site; standard of care; Sterile coverings; Stomach; Sulfhydryl Compounds; Swelling; System; Testing; Therapeutic Embolization; tool; Toxic effect; Treatment Cost; United States; Venous Pressure level; wound

Serious non-variceal upper gastrointestinal bleeding (NVUGIB) is a major cause of morbidity and mortality worldwide. Incidence of NVUGIB in the US is close to 50 events per 100,000 adults, with approximately 160,000 hospital admissions annually. US treatment and prevention of NVUGIB continues to be a major medical emergency, costing 550-900 million dollars every year. Failure in standard of care for NVUGIB results in mortality rates from 3-4% in the US. An improved hemostatic approach to NVUGIB will significantly reduce hemorrhage related morbidity and mortality with reduced cost of hospital care. The ideal device would be nontoxic; able to be stored for 2 years without refrigeration; be easily deployed; provide immediate hemostasis for difficult to control brisk & pulsatile bleeding; allow successful low accuracy/acuity placement in a bleeding obscured surgical field; not require significant follow-up or removal; and dissolve or be digested in the gastric cavity in under 7 days. This proposal addresses finalization in development of such a device. To address serious NVUGIB, Tricol Biomedical & Oregon Health & Science University propose to finalize development of a foldable, highly efficacious, chitosan gastrointestinal hemostatic dressing (CGHD) with wire delivery (WD) via a standard endoscope working channel. The primary objective of this research proposal is to complete development of a novel efficacious CGHD+DW and its management of challenging acute GI bleeding in the gastric environment that can be left in place to be fully digested or dissolved in less than 168 hours. The final CGHD+WD device will be validated in a 7-day study of a large animal model of brisk, pulsatile UGIB to support an investigational device exemption (IDE) for a Phase I clinical study. The central hypothesis of this Phase II proposal is that the finalized CGHD+DW with delivery through the standard endoscope working channel will provide effective, immediate and sustained hemostasis for brisk NVUGIB.

Public Health Relevance Statement:
Narrative Serious non-variceal upper gastrointestinal bleeding (NVUGIB) is a major cause of morbidity and mortality worldwide with incidence of NVUGIB in the US close to 50 events per 100,000 adults, with approximately 160,000 hospital admissions annually. The chitosan gastrointestinal hemostatic dressing (CGHD) delivered by wire (WD) via the working channel of a standard endoscope will provide for rapid deployment of an advanced, tissue adherent, hemostatic dressing to provide immediate hemostasis for difficult to control NVUGIB and allow for successful low accuracy/acuity placement in an obscured surgical field without need for significant follow-up or removal. The successfully completed CGHD+DW device will significantly reduce NVUGIB hemorrhage related morbidity and mortality with reduced cost of hospital care.

Project Terms:
Acute; Address; Adherence; Adhesions; Admission activity; Adult; Animal Model; Animals; arm; biomaterial compatibility; Blood; Caliber; Caring; Catechols; Cattle; Chemistry; Chitosan; Chronic; Citrates; Classification; Clinical Research; Coagulation Process; cost; design; Development; Devices; Digestion; Endoscopes; Environment; Event; Excision; experimental arm; Failure; Family suidae; Fiber; follow-up; Freeze Drying; gastrointestinal; Gastrointestinal Hemorrhage; healing; Health Sciences; Hemorrhage; Hemostatic Agents; Hemostatic function; Histologic; Hospital Costs; Hospitalization; Hospitals; Hour; improved; In Vitro; in vivo; Incidence; Infection; injured; Injury; Interventional radiology; Investigation; Left; Length of Stay; Liquid substance; Mechanics; Medical Device; Medical emergency; meetings; Membrane; Modeling; Monitor; Morbidity - disease rate; mortality; Mucous Membrane; novel; Operative Surgical Procedures; Oregon; Phase; phase 1 study; phase 2 designs; Postoperative Period; Preparation; pressure; Prevention; Procedures; product development; prototype; Reaction; Refrigeration; Regulatory Pathway; Research Proposals; Resistance; Secure; Site; splenic injury; standard of care; Sterile coverings; Stomach; success; Suction; Surface; Testing; Thinness; Tissues; Universities; Validation; Variant; Visual; White Blood Cell Count procedure; wound; Wound Healing