Neurostimulation for the Treatment of Post-Operative Ileus

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.

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