Neurostimulation for the Treatment of Post-Operative Ileus

ElectroCore

Status

Withdrawn

Conditions

Ileus

Treatments

Device: ElectroCore RMS-1100 Resolution Motility System™

Study type

Interventional

Funder types

Industry

Identifiers

NCT00854074

IL - 01

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No 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:

i. 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