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Treatment of Gastroparesis with Multi-Channel Pacing

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41DK071350-01
Agency Tracking Number: DK071350
Amount: $99,956.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 2005
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
Gi Stimulation, Inc. 500 Old Lynchburg Rd, Ste A
Charlottesville, VA 22903
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 ZHIYUE LIN
 (913) 588-4025
 ZLIN@KUMC.EDU
Business Contact
 ROBERT ROSS
Phone: (434) 970-2200
Email: Ross@gistimulation.com
Research Institution
 UNIVERSITY OF KANSAS MEDICAL CENTER
 
UNIVERSITY OF KANSAS MEDICAL CENTER MSN 1039
KANSAS CITY, KS 66160
United States

 Nonprofit College or University
Abstract

DESCRIPTION (provided by applicant): The goal of this project is to investigate the safety and efficacy of multi-channel gastric electrical stimulation (MGS) in the treatment of patients with diabetic gastroparesis refractory to standard medical therapy. Previous animal studies have shown that appropriate multi-channel electrical stimulation of the stomach will: a) entrain gastric myoelectrical activity and thus normalize myoelectrical dysrhythmia; b) improve coupling of gastric myoelectrical activity and thus improve gastric peristaltic waves; c) be more efficient than single channel electrical stimulation by requiring substantially lower energy and is therefore more feasible for permanent surgical implantation of a battery powered pacemaker as a future goal. The proposed clinical study will be performed at the University of Kansas Medical Center and has received both FDA IDE and institutional approvals. The primary parameters assessed will be percentage of gastric retention of a solid meal, severity scores of upper gastrointestinal symptoms, quality of life assessment and monitoring of adverse events. It is hypothesized that MGS will result in accelerated gastric emptying of solids and improved symptoms of gastroparesis and quality of life. The success of this project would demonstrate the feasibility of MGS as a therapeutic approach for the treatment of diabetic gastroparesis and would then lead to the next steps of development and test of a permanently implanted device. The MGP-1 Multi-channel Gastric Pacemaker to be used in the proposed clinical study was developed by Virginia Technologies, Inc. and funded through a successful NIH NIDDK SBIR I grant (1 R43 DK58487-01). Development of the MGP-2, and implantable version of the MGP-1, is currently being funded through an NIH NIDDK SBIR II grant (2 R44 DK058487-02). Phase II of this project will investigate the safety and efficacy of the MGP-2 in human subjects.

* Information listed above is at the time of submission. *

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