IleusNCT00854074

Neurostimulation for the Treatment of Post-Operative Ileus

A study testing ElectroCore RMS-1100 Resolution Motility System™ in people with Ileus, run by ElectroCore INC at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Ileus
What is being tested?: ElectroCore RMS-1100 Resolution Motility System™
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 3 sitesUnited States
Study dates: Jul 2009to Jan 2010
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
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

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Johns Hopkins Medical Center
Baltimore, Maryland, 21205
Northwestern
Chicago, Illinois, 60611
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106

Other trials in United States

About this study

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

Read the 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.

Conditions: Ileus
Being tested: ElectroCore RMS-1100 Resolution Motility System™
Keywords: Post-operative Paralytic Ileus, Neuromodulation, Neurostimulation, Extended loss of functional bowel motility
Medical subject headings: Ileus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00854074
Study group	Role	What they receive
2	No intervention	Subject will be observed until recovery of normal GI function
1	Experimental	Spinal neurostimulation Receives: Device: ElectroCore RMS-1100 Resolution Motility System™

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Jan 2010

First posted2 Mar 2009 (estimated)
Study startJul 2009
Primary completionDec 2009 (estimated)
Study completionJan 2010 (estimated)

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

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for IleusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00854074
Sponsor's protocol ID: IL - 01
Status last verified: Feb 2018
First submitted: 26 Feb 2009
Last updated: 19 Feb 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Effect of Ostomy Care Education Applied With the Teach-Back Method to Ostomy-Opened Individuals on Self-Care Power, Ostomy Adjustment, and Anxiety
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All Ileus trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neurostimulation for the Treatment of Post-Operative Ileus
ClinicalTrials.gov ID: NCT00854074
Acronym / sponsor ID: IL - 01
Conditions: Ileus
Keywords: Post-operative Paralytic Ileus, Neuromodulation, Neurostimulation, Extended loss of functional bowel motility
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Withdrawn: study halted prematurely, prior to enrollment of first participant
Enrolment: 0 participants (actual)
Lead sponsor: ElectroCore INCIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Dec 2009 (estimated)
Study completion: Jan 2010 (estimated)
First posted: 2 Mar 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
2	No intervention	–Subject will be observed until recovery of normal GI function
1	Experimental	Device: ElectroCore RMS-1100 Resolution Motility System™Spinal neurostimulation

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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:

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ElectroCore RMS-1100 Resolution Motility System™An electrical neurostimulation signal will be applied to the spine	Device	1

Primary outcome

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

1 secondary outcome

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

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.

Related trials for Ileus

Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingObservational study
The Effect of Ostomy Care Education Applied With the Teach-Back Method to Ostomy-Opened Individuals on Self-Care Power, Ostomy Adjustment, and Anxiety
Ostomy - Ileostomy or Colostomy, Canser

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Erdeck, MD principal investigator

Johns Hopkins Medical Center

David Walega, MD principal investigator

Northwestern University Medical Center

Robert Frye, MD principal investigator

Pennsylvania Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ElectroCore RMS-1100 Resolution Motility System™ in people with Ileus, run by ElectroCore INC at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00854074.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.