Neurostimulation for the Treatment of Post-Operative Ileus - Full Text View

Sponsored by:	ElectroCore LLC
Information provided by:	ElectroCore LLC
ClinicalTrials.gov Identifier:	NCT00854074

Purpose

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	Intervention	Phase
Ileus	Device: ElectroCore RMS-1100 Resolution Motility System™	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Neurostimulation for the Treatment of Post-Operative Ileus

Further study details as provided by ElectroCore LLC:

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 [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 8 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	March 2009
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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 > 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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	ElectroCore LLC ( Robert Newman )
Study ID Numbers:	IL - 01
Study First Received:	February 26, 2009
Last Updated:	February 27, 2009
ClinicalTrials.gov Identifier:	NCT00854074 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by ElectroCore LLC:

Post-operative Paralytic Ileus
Neuromodulation
Neurostimulation
Extended loss of functional bowel motility

Study placed in the following topic categories:

Intestinal Obstruction
Morphine
Ileus

Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

Additional relevant MeSH terms:

Intestinal Obstruction
Ileus
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 11, 2009