NCT00854074

Neurostimulation for the Treatment of Post-Operative Ileus

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ElectroCore INC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Ileus

Interventions

Type	Name	Description
DEVICE	ElectroCore RMS-1100 Resolution Motility System™	An electrical neurostimulation signal will be applied to the spine

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2009-03-02
• Last updated: 2018-02-19

Locations

3 sites across 1 country: United States