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Neurostimulation for the Treatment of Post-Operative Ileus

Primary Purpose

Ileus

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ElectroCore RMS-1100 Resolution Motility System™

About this trial

This is an interventional treatment trial for Ileus focused on measuring Post-operative Paralytic Ileus, Neuromodulation, Neurostimulation, Extended loss of functional bowel motility

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Northwestern
Johns Hopkins Medical Center
Pennsylvania Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Arm Description

Subject will be observed until recovery of normal GI function

Spinal neurostimulation

Outcomes

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

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.

Full Information

NCT ID

NCT00854074

First Posted

February 26, 2009

Last Updated

February 15, 2018

Sponsor

ElectroCore INC

1. Study Identification

Unique Protocol Identification Number

NCT00854074

Brief Title

Neurostimulation for the Treatment of Post-Operative Ileus

Official Title

Neurostimulation for the Treatment of Post-Operative Ileus

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Withdrawn: study halted prematurely, prior to enrollment of first participant

Study Start Date

July 2009 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

January 2010 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ElectroCore INC

4. Oversight

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ileus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

Subject will be observed until recovery of normal GI function

Arm Title

Arm Type

Experimental

Arm Description

Spinal neurostimulation

Intervention Type

Device

Intervention Name(s)

ElectroCore RMS-1100 Resolution Motility System™

Intervention Description

An electrical neurostimulation signal will be applied to the spine

Primary Outcome Measure Information:

Title

Time Frame

30 days

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Erdeck, MD

Organizational Affiliation

Johns Hopkins Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David Walega, MD

Organizational Affiliation

Northwestern University Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robert Frye, MD

Organizational Affiliation

Pennsylvania Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Johns Hopkins Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Facility Name

Pennsylvania Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19106

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Neurostimulation for the Treatment of Post-Operative Ileus

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