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Neurostimulation for the Treatment of Post-Operative Ileus

This study has been withdrawn prior to enrollment.
(Withdrawn: study halted prematurely, prior to enrollment of first participant)
Sponsor:
Information provided by:
ElectroCore LLC
ClinicalTrials.gov Identifier:
NCT00854074
First received: February 26, 2009
Last updated: January 18, 2010
Last verified: January 2010
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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: 30 days ] [ 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: 48 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: July 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854074

Locations
United States, Illinois
Northwestern
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21205
United States, Pennsylvania
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19106
Sponsors and Collaborators
ElectroCore LLC
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
  More Information

No publications provided

Responsible Party: Heather Stitzel, ElectroCore LLC
ClinicalTrials.gov Identifier: NCT00854074     History of Changes
Other Study ID Numbers: IL - 01
Study First Received: February 26, 2009
Last Updated: January 18, 2010
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

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013