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Temporary Gastric Electrical Stimulation for Gastroparesis

This study has suspended participant recruitment.
Sponsor:
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT01054794
First received: January 19, 2010
Last updated: November 19, 2010
Last verified: November 2010
History of Changes
  Purpose

This is a prospective study of temporary gastric mucosal electrical stimulation (tGES) in 30 patients with gastroparesis (GP). After a 7 day baseline assessment of symptoms, subjects will have an endoscopically-placed tGES lead implanted into the mucosa of the antrum. This lead is connected to a thin wire that runs up the esophagus and out the nostril, similar to a nasojejunal feeding tube, although much thinner. It is then attached to a programmable battery pack which provides the desired level of stimulation.

Patients will then be randomized to 7 days OFF or 7 days ON stimulation in a double-blind fashion. After 7 days, subjects will crossover to the other study arm (ie ON patients will be switched off; OFF patients will be switched on). Symptoms and QoL measures will be assessed at baseline, ON, and OFF periods. Serum ghrelin and other hormones, as well as EGG will be assayed after 6 days in each arm.


Condition Intervention
Gastroparesis
 Device: Gastric mucosal stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Temporary Gastric Neurostimulation for Gastroparesis

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Changes in patient symptoms during the ON and OFF periods of tGES stimulation. [ Time Frame: daily x 6 days in each phase of study (ON and OFF) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. Changes in serum ghrelin and leptin between ON and OFF periods of tGES stimulation in GP patients. 2. Changes in gastric electrical activity between ON and OFF periods of tGES stimulation in GP patients [ Time Frame: Once during each study phase (ON and OFF) ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stimulation ON Device: Gastric mucosal stimulation
The lead is a sterile, 2mm diameter insulated wire (Temporary Transvenous Pacing Lead 6416-200cm, Medtronic, Minneapolis, MN) with 2 electrodes on the distal end. The mucosal stimulation parameters(Current:10 mA; Frequency: 14Hz; Pulse width: 330 ms; Cycle ON: 0.1 s; Cycle OFF: 5 s) are within the range used for standard permanent implanted GES (Enterra therapy) within the serosa and muscle layers of the stomach, and which has been shown to be safe, without any tissue damage.
Sham Comparator: Stimulation OFF Device: Gastric mucosal stimulation
The lead is a sterile, 2mm diameter insulated wire (Temporary Transvenous Pacing Lead 6416-200cm, Medtronic, Minneapolis, MN) with 2 electrodes on the distal end. The mucosal stimulation parameters(Current:10 mA; Frequency: 14Hz; Pulse width: 330 ms; Cycle ON: 0.1 s; Cycle OFF: 5 s) are within the range used for standard permanent implanted GES (Enterra therapy) within the serosa and muscle layers of the stomach, and which has been shown to be safe, without any tissue damage.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of 18 or older
  • Existing clinical diagnosis of gastroparesis for at least one year as judged by the study gastroenterologist based on past medical history, clinical symptoms
  • Sufficiently symptomatic at time of proposed study (Minimum total baseline GCSI score of 1.5 or higher)
  • Delayed gastric emptying (>10% retention at 4 hours) on standard scintigraphic emptying study with patients off narcotics for at least 48 hours. Normal upper endoscopy (with the exception of small bezoars) since the onset of symptoms
  • Medically fit to undergo endoscopy
  • Able and willing to remain in Calgary for the duration of the study (baseline period excepted)
  • Able to provide written informed consent

Exclusion Criteria:

  • Clinical evidence (including physical exam and/or EKG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
  • Current use of anticoagulants, ASA, NSAIDS, clopidogrel, etc. which cannot safely be stopped for up to 5 days prior to the procedure in the opinion of the investigators
  • Bleeding diathesis
  • Severe immunocompromise
  • Physical, mental, or compliance issues which in the opinion of the investigators may prevent the patient from completing the study
  • Pregnant or breastfeeding females
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01054794

Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Christopher N Andrews, MD, FRCPC University of Calgary, Faculty of Medicine
  More Information

No publications provided

Responsible Party: Christopher N. Andrews, MD FRCPC, University of Calgary, Faculty of Medicine
ClinicalTrials.gov Identifier: NCT01054794     History of Changes
Other Study ID Numbers: TS01
Study First Received: January 19, 2010
Last Updated: November 19, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
Gastroparesis
Gastric Electrical Stimulation

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013