Neurostimulation for the Treatment of Post-Operative Ileus

Sponsor

ElectroCore INC (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00854074

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ileus	Device: ElectroCore RMS-1100 Resolution Motility System™	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Neurostimulation for the Treatment of Post-Operative Ileus

Study Start Date :

Jul 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 2 Subject will be observed until recovery of normal GI function
Experimental: 1 Spinal neurostimulation	Device: ElectroCore RMS-1100 Resolution Motility System™ An electrical neurostimulation signal will be applied to the spine

Arm

Intervention/Treatment

No Intervention: 2

Subject will be observed until recovery of normal GI function

Experimental: 1

Spinal neurostimulation

Device: ElectroCore RMS-1100 Resolution Motility System™

An electrical neurostimulation signal will be applied to the spine

Outcome Measures

Primary Outcome Measures

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 [30 days]

Secondary Outcome Measures

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. [48 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or Female, Age >18 years, < 65 years
Partial small or large bowel open resection with primary anastomosis
120 hours post-operative with no signs of functional bowel activity
Able to give Informed Consent
By Post-Op Day 5, patient care has involved at least 3 of the following conservative therapies to minimize long term POI:

post-operative, patient controlled opioid analgesia ii. removal of intra-operative nasogastric tube at time of surgery or on post-operative day 1 iii. advancement of liquid diet iv. advancement of solid food v. ambulation vi. use of chewing gum

Exclusion Criteria:

Pregnant
Undergoing surgery for repair of penetrating trauma injury, gangrene or ischemic bowel
Evidence of anastomotic leak, abdominal infection, sepsis, bowel perforation, mechanical small bowel obstruction or metabolic derangement (e.g., low potassium/magnesium)
Presence of existing implanted or external stimulator for pain or other indications (including pacemaker)
Operative blood lost of > 500 cc
Significant scarring of the skin along the lower thoracic/lumbar spine or deformation of thoracic spinal canal from congenital, developmental or traumatic causes, or previous extensive spinal thoracic surgery other than diskectomy
Received a lumbar or thoracic epidural block placed immediately prior to surgery
Body Mass Index > 35
Unstable cardiac status
Severe hypertension
American Society of Anesthesiologists (ASA) Score greater than/equal to 3
On anti-coagulation therapy (other than aspirin) or has an underlying bleeding disorder
Active or suspected pelvic infection
Unable to communicate perception of the stimulation
Significant surgical complications where in the view of the physician, participation in the study could further complicate subject care (i.e. infection at surgical site, deep venous thrombosis, respiratory complications, etc)
Treatment with Entereg (alvimopam) during post-operative period

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern	Chicago	Illinois	United States	60611
2	Johns Hopkins Medical Center	Baltimore	Maryland	United States	21205
3	Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19106

Sponsors and Collaborators

ElectroCore INC

Investigators

Principal Investigator: Michael Erdeck, MD, Johns Hopkins Medical Center
Principal Investigator: David Walega, MD, Northwestern University Medical Center
Principal Investigator: Robert Frye, MD, Pennsylvania Hospital