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Neurostimulation for the Treatment of Post-Operative Ileus

15. februar 2018 opdateret af: ElectroCore INC
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

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 2
Subject will be observed until recovery of normal GI function
Eksperimentel: 1
Spinal neurostimulation
Enhed: ElectroCore RMS-1100 Resolution Motility System™
An electrical neurostimulation signal will be applied to the spine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: 30 days
30 days

Sekundære resultatmål

Resultatmål
Tidsramme
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.
Tidsramme: 48 hours
48 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ElectroCore INC

Efterforskere

  • Ledende efterforsker: Michael Erdeck, MD, Johns Hopkins Medical Center
  • Ledende efterforsker: David Walega, MD, Northwestern University Medical Center
  • Ledende efterforsker: Robert Frye, MD, Pennsylvania Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2009

Primær færdiggørelse (Forventet)

1. december 2009

Studieafslutning (Forventet)

1. januar 2010

Datoer for studieregistrering

Først indsendt

26. februar 2009

Først indsendt, der opfyldte QC-kriterier

27. februar 2009

Først opslået (Skøn)

2. marts 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. februar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. februar 2018

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IL - 01

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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