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Temporary Gastric Electrical Stimulation for Gastroparesis

Primary Purpose

Gastroparesis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Gastric mucosal stimulation
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis focused on measuring Gastroparesis, Gastric Electrical Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Stimulation ON

Stimulation OFF

Arm Description

Outcomes

Primary Outcome Measures

Changes in patient symptoms during the ON and OFF periods of tGES stimulation.

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

Full Information

First Posted
January 19, 2010
Last Updated
June 19, 2015
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT01054794
Brief Title
Temporary Gastric Electrical Stimulation for Gastroparesis
Official Title
Temporary Gastric Neurostimulation for Gastroparesis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
Keywords
Gastroparesis, Gastric Electrical Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stimulation ON
Arm Type
Active Comparator
Arm Title
Stimulation OFF
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Gastric mucosal stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher N Andrews, MD, FRCPC
Organizational Affiliation
University of Calgary, Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada

12. IPD Sharing Statement

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Temporary Gastric Electrical Stimulation for Gastroparesis

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