Neurostimulation for the Treatment of Post-Operative Ileus

Ileus Clinical Trial

Official title:

Neurostimulation for the Treatment of Post-Operative Ileus

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00854074
• Other study ID #: IL - 01
• Status: Withdrawn
• Phase: N/A
• First received: February 26, 2009
• Last updated: February 15, 2018
• Start date: July 2009
• Est. completion date: January 2010

Study information

• Verified date: February 2018
• Source: ElectroCore LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ileus

Intervention

Device:
• ElectroCore RMS-1100 Resolution Motility System™
An electrical neurostimulation signal will be applied to the spine

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Center	Baltimore	Maryland
United States	Northwestern	Chicago	Illinois
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
ElectroCore LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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