Neurostimulation for the Treatment of Post-Operative Ileus

NCT00854074 | Withdrawn

• 1 other identifier: IL - 01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Ileus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

2

NO INTERVENTION

Subject will be observed until recovery of normal GI function

1

EXPERIMENTAL

Spinal neurostimulation

Device: ElectroCore RMS-1100 Resolution Motility System™

Interventions

ElectroCore RMS-1100 Resolution Motility System™ DEVICE

An electrical neurostimulation signal will be applied to the spine

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female, Age \>18 years, \< 65 years
• Partial small or large bowel open resection with primary anastomosis
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• ElectroCore INC: lead

Study Sites (3)

Northwestern

Chicago, Illinois, 60611, United States

Location

Johns Hopkins Medical Center

Baltimore, Maryland, 21205, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

Location

MeSH Terms

Conditions

Ileus

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Michael Erdeck, MD

  Johns Hopkins Medical Center

  PRINCIPAL INVESTIGATOR

• David Walega, MD

  Northwestern University Medical Center

  PRINCIPAL INVESTIGATOR

• Robert Frye, MD

  Pennsylvania Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: March 2, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

US (3)