Clinical Trial: Neurostimulation for the Treatment of Post-Operative Ileus

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Neurostimulation for the Treatment of Post-Operative Ileus

Brief Summary: The primary goal of this study is to validate the design of the ElectroCore RMS-1100 Resolution Motility System™ and the ability to safely place a stimulation electrode in the epidural space of the spine in a post-operative subject, and to evaluate the subject's ability to tolerate stimulation for up to 48 hours. The secondary goal is to confirm that the electrical signal being delivered via this electrode shows evidence of effectiveness in improving the functional GI motility in subjects experiencing post-operative paralytic ileus

Detailed Summary:

The purpose of this study is to investigate the effects of neurostimulation in the epidural space in the spine on the activity of the enteric nervous system (ENS).

ElectroCore has successfully studied POI in an animal model and believes that temporary neurostimulation of the spine may be useful in re-starting the ENS in humans, resulting in the resumption of coherent GI motility in the gut and normal bowel function in a shorter period of time than currently occurs. Electrical pulses will be used to modulate the signals that may be preventing a return to normal GI activity. This device and procedure used in this study are similar to the system and procedure used to implant the temporary trial stimulator used evaluate the effectiveness of spine pain stimulation prior to implantation of the permanent device.

Sponsor: ElectroCore LLC

Current Primary Outcome: To validate the design of ElectroCore Resolution Motility System™ , to safely place a stimulation electrode in the epidural space of the spine in a post-operative subject, and to evaluate the subject's ability to tolerate stimulation for up to 48 hours [ Time Frame: 30 days ]

Original Primary Outcome: To validate the design of ElectroCore Resolution Motility System™ , to safely place a stimulation electrode in the epidural space of the spine in a post-operative subject, and to evaluate the subject's ability to tolerate stimulation for up to 48 hours [ Time Frame: 8 months ]

Current Secondary Outcome: To confirm that the electrical signal being delivered via this electrode shows evidence of effectiveness in improving the functional motility in subjects experiencing post-operative paralytic ileus. [ Time Frame: 48 hours ]

Original Secondary Outcome: To confirm that the electrical signal being delivered via this electrode shows evidence of effectiveness in improving the functional motility in subjects experiencing post-operative paralytic ileus. [ Time Frame: 8 Months ]

Information By: ElectroCore LLC

Dates:
Date Received: February 26, 2009
Date Started: July 2009
Date Completion: January 2010
Last Updated: February 15, 2016
Last Verified: February 2016